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

23. Juli 2016 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Propofol Induced Hypotension

Intervention / Behandlung

Detaillierte Beschreibung

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%.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

150

Phase

Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Indien
- Dakshina Kannada
  - Mangalore, Dakshina Kannada, Indien, 575018
    - Rekrutierung
    - Justice K. S. Hegde Hospital, K S Hegde Medical Academy, Nitte University
    - Kontakt:
      
      Sripada G Mehandale, MBBS, MD
      
      Telefonnummer: 09448384310
      
      E-Mail: dr_sgmehandale@rediffmail.com
    - Kontakt:
      
      Sara Jaison, MBBS
      
      Telefonnummer: 09900632065
      
      E-Mail: sara_jaison@yahoo.co.in
    - Hauptermittler:
      
      Sara Jaison, MBBS

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Verhütung
Zuteilung: Zufällig
Interventionsmodell: Parallele Zuordnung
Maskierung: Keine (Offenes Etikett)

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Placebo-Komparator: 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.	Sonstiges: 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.	Sonstiges: 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.	Sonstiges: leg wrapping Esmarch bandage is used to wrap each lower limb

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
incidence of hypotension at baseline Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Sekundäre Ergebnismessungen

Andere Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Need for pharmacological measures to treat hypotension Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nitte University

Ermittler

Studienleiter: Sripada G Mehandale, MBBS, MD, Associate Professor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2016

Primärer Abschluss (Voraussichtlich)

1. August 2017

Studienabschluss (Voraussichtlich)

1. Dezember 2017

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juli 2016

Zuerst gepostet (Schätzen)

27. Juli 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

27. Juli 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juli 2016

Zuletzt verifiziert

1. Juli 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

INST.EC/EC/066/2015-16

Plan für individuelle Teilnehmerdaten (IPD)

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Beschreibung des IPD-Plans

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

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