Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension

July 23, 2016 updated by: Dr. Sara Jaison, Nitte University

Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension: A Prospective Randomised Controlled Study

Propofol is an intravenous anaesthetic agent used for both induction and maintenance of anaesthesia. An important adverse effect is the significant fall in blood pressure. The current clinical study will be done to determine the efficacy of leg elevation and wrapping in reducing the incidence and severity of propofol induced hypotension in patients undergoing general anaesthesia.

Study Overview

Status

Unknown

Conditions

Propofol Induced Hypotension

Intervention / Treatment

Detailed Description

Propofol is an intravenous anaesthetic agent used for both induction and maintenance of anaesthesia. It is widely employed due to its quick onset of action, short half life and rapid recovery. An important adverse effect is the significant fall in blood pressure. Although the exact mechanism of propofol induced hypotension is not known, venodilation, decreased peripheral resistance and decrease in cardiac output has been suggested.2 Though the hypotension is transient, it can produce devastating effects. Hence there is a need to prevent it. Moreover, several attempts at treating propofol induced hypotension have been met with variable and limited success.

Hypotension following spinal anaesthesia is also a frequent problem. It is generally treated with intravenous fluids and vasopressors. Simple and non pharmacological measures like leg elevation and leg wrapping with Esmarch bandage were reported to be successful.3 These reduce the incidence and severity of hypotension associated with spinal anaesthesia by improving the venous return.

The mechanisms of hypotension following intravenous propofol and spinal anaesthesia are almost similar. Therefore, the investigators hypothesize that leg elevation and wrapping can be attempted to reduce propofol induced hypotension. They are simple and cost effective techniques that will reduce the need for pharmacological measures to control hypotension. As the literature search did not reveal any information regarding the usefulness of these techniques in propofol induced hypotension, the current clinical study will be done to determine the efficacy of leg elevation and wrapping in reducing the incidence and severity of propofol induced hypotension in patients undergoing general anaesthesia.

The current study will compare the efficacy of leg elevation and leg wrapping in reducing the incidence and severity of propofol induced hypotension in terms of incidence of hypotension, magnitude of decrease in systolic, diastolic and mean arterial blood pressures, need for pharmacological measures to treat hypotension, changes in heart rate and adverse clinical outcomes, if any. It will be a prospective randomised controlled open label study from January 2016 to August 2017 involving 150 adult patients undergoing general anaesthesia.

For statistical analysis, descriptive statistics - minimum, maximum, mean and standard deviation will be used. Independent sample t test for data following normal distribution and for data not following normal distribution, Mann-Whitney U test will be used. P value less than 0.05 will be considered statistically significant. To study relationship between hypotension and other variables, Pearson's correlation will be used. Confidence interval will be calculated to 95%.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

India
- Dakshina Kannada
  - Mangalore, Dakshina Kannada, India, 575018
    - Recruiting
    - Justice K. S. Hegde Hospital, K S Hegde Medical Academy, Nitte University
    - Contact:
      
      Sripada G Mehandale, MBBS, MD
      
      Phone Number: 09448384310
      
      Email: dr_sgmehandale@rediffmail.com
    - Contact:
      
      Sara Jaison, MBBS
      
      Phone Number: 09900632065
      
      Email: sara_jaison@yahoo.co.in
    - Principal Investigator:
      
      Sara Jaison, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients belonging to ASA physical status I and II undergoing endotracheal general anaesthesia

Exclusion Criteria:

Patient refusal
Contraindication to application of bandage
Partial or complete limb amputation
Difficult airway
Use of extraglottic airway device
Pregnancy
On antihypertensive or vasoactive medication
Autonomic neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group C Control Patient will be shifted to operation theatre. Electrocardiography (ECG), pulse oximeter and non-invasive blood pressure (NIBP) monitors will be attached. Baseline vitals will be noted. Intravenous access will be secured and crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be neither elevated or wrapped. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube.	Other: control no intervention has been done
Experimental: Group E Leg elevation Patient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs are elevated and supported on a stand making an angle of 30 degree to the horizontal. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Stand will be removed and legs will be brought to horizontal position 10 minutes after intubation.	Other: leg elevation A stand making an angle of 30 degree to the horizontal is used to elevate both the legs
Experimental: Group W Leg wrapping Patient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl. Each lower limb will be elevated alternately and wrapped from toe to mid-thigh with Esmarch bandage. Care will be taken to avoid compressing the legs to greater than arterial pressure by confirming the presence of pulse using a saturation probe. Following wrapping, the lower limbs will be brought to horizontal position. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol injected over 30 seconds. Muscle relaxation by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Esmarch bandage will be removed 10 minutes after intubation.	Other: leg wrapping Esmarch bandage is used to wrap each lower limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypotension at baseline Time Frame: baseline	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	baseline
incidence of hypotension at 0 minutes after leg elevation or wrapping Time Frame: 0 minutes after leg elevation or wrapping	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	0 minutes after leg elevation or wrapping
incidence of hypotension at 0 minutes after induction with propofol Time Frame: 0 minutes after induction with propofol	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	0 minutes after induction with propofol
incidence of hypotension at 1 minute after induction Time Frame: 1 minute after induction	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	1 minute after induction
incidence of hypotension at 2 minutes after induction Time Frame: 2 minutes after induction	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	2 minutes after induction
incidence of hypotension at 3 minutes after induction Time Frame: 3 minutes after induction	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	3 minutes after induction
incidence of hypotension at 4 minutes after induction Time Frame: 4 minutes after induction	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	4 minutes after induction
incidence of hypotension at 5 minutes after induction Time Frame: 5 minutes after induction	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	5 minutes after induction
incidence of hypotension at 0 minutes after intubation Time Frame: 0 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	0 minutes after intubation
incidence of hypotension at 1 minute after intubation Time Frame: 1 minute after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	1 minute after intubation
incidence of hypotension at 2 minutes after intubation Time Frame: 2 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	2 minutes after intubation
incidence of hypotension at 3 minutes after intubation Time Frame: 3 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	3 minutes after intubation
incidence of hypotension at 4 minutes after intubation Time Frame: 4 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	4 minutes after intubation
incidence of hypotension at 5 minutes after intubation Time Frame: 5 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	5 minutes after intubation
incidence of hypotension at 6 minutes after intubation Time Frame: 6 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	6 minutes after intubation
incidence of hypotension at 7 minutes after intubation Time Frame: 7 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	7 minutes after intubation
incidence of hypotension at 8 minutes after intubation Time Frame: 8 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	8 minutes after intubation
incidence of hypotension at 9 minutes after intubation Time Frame: 9 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	9 minutes after intubation
incidence of hypotension at 10 minutes after intubation Time Frame: 10 minutes after intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.	10 minutes after intubation

Secondary Outcome Measures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for pharmacological measures to treat hypotension Time Frame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation	Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure (MAP) will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. MAP will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol. MAP will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed. MAP<55mm Hg will be treated by rapid intravenous fluid administration and by intravenous mephentermine 6mg bolus increments every minute until the systolic pressure rises to greater than 70% of baseline or to above 90mm Hg. Total dose of mephentermine required will be noted.	baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
Tachycardia Time Frame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation	Tachycardia will be defined as heart rate more than 100bpm or increase by more than 30% over baseline value. Any incidence of tachycardia during the procedure will be noted	baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
Bradycardia Time Frame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation	Bradycardia will be defined as heart rate less than 50bpm or decrease by more than 30% below baseline value. Any incidence of bradycardia during the procedure will be noted	baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
Arrhythmia Time Frame: baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation	any incidence of arrhythmia during the procedure will be noted	baseline, after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nitte University

Investigators

Study Director: Sripada G Mehandale, MBBS, MD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 23, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 23, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

INST.EC/EC/066/2015-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Age, sex, weight, diagnosis, surgery, asa physical status, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Propofol Induced Hypotension

Hyungmook Lee

Unknown

Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol

Hypotension | Propofol

Korea, Republic of
Nanfang Hospital, Southern Medical University

Recruiting

Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study

Sedation | Propofol | Low Blood Pressure | Norepinephrine | Ciprofol

China
Asan Medical Center

Recruiting

Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery

Orthopedic Procedures | Propofol | Anesthesia, Spinal | Remimazolam | Sedatives

Korea, Republic of
Xingui Dai

Unknown

A Warmer Temperature Decrease Propofol Injection Pain

Injection Site Irritation | Temperature Change, Body | Propofol Syndrome

China
Fondazione Policlinico Universitario Agostino Gemelli...

Not yet recruiting

Hypotension Prediction Index vs Norepinephrine Infusion for Prevention of Spinal Hypotension for Cesarean Delivery

Hypotension Drug-Induced | Hypotension During Surgery
Damanhour Teaching Hospital

Recruiting

Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries

Hypotension Drug-Induced

Egypt
Damanhour Teaching Hospital

Completed

Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?

Hypotension Drug-Induced

Egypt
Ain Shams University

Completed

Ephedrine Versus Ondansetron During Cesarean Delivery

Spinal Induced Hypotension

Egypt
Suez Canal University

Completed

Granisetron in Diabetic Parturients Decrease Spinal Induced Hypotension

Spinal-induced Hypotension

Egypt
Duke University

Completed

PVI for Prediction of Spinal Induced Hypotension

Spinal Induced Hypotension

United States

Clinical Trials on control

Claudia M. Witt

Completed

XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

Stroke

Germany
University of California, San Francisco

Withdrawn

Work of Breathing and Mechanical Ventilation in Acute Lung Injury (WOBALI)

Acute Lung Injury
The George Institute
Changhai Hospital; University of Calgary

Not yet recruiting

Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial (ENCHANTED3/MT)

Ischemic Stroke, Acute
Universidad Nacional de Educación a Distancia
Ministerio de Economía y Competitividad, Spain

Unknown

An Emotional Regulation Brief Procedure (PbRE) for Fibromyalgia Using ICT's (PbRE)

Chronic Pain | Fibromyalgia

Spain
University of California, Los Angeles
The National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...

Completed

Aging Mastery Program® (AMP) Evaluation (AMP)

Healthy | Aging | Older Adults

United States
Queen's University, Belfast
Public Health Agency, Health and Social Care Research and Development; Tiny...

Completed

Attention Control Training (ACT) and Very Preterm Infants (ACT)

Very Premature Baby

United Kingdom
National Taiwan University Hospital

Enrolling by invitation

Cognitive Function in Patients With Persisted Atrial Fibrillation (SMART-AF)

Cognitive Function | Atrial Fibrillation, Persistent

Taiwan
Takeshi Morimoto
University of the Ryukyus

Active, not recruiting

Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease

Coronary Artery Disease | Hypertension | Type 2 Diabetes | Dyslipidemia

Japan
Johnson & Johnson Vision Care, Inc.

Terminated

Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process

Refractive Error Correction

United States
Vanderbilt University Medical Center

Completed

Mode Of Ventilation During Critical IllnEss Pilot Trial (MODE)

Respiratory Failure

United States

Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension