Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia.

Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia. a Randomized Comparative Trial.

The investigators will test the hemodynamic effects of a high dose versus low dose Propofol during induction of anesthesia.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamic Effects of Propofol
• Intervention / Treatment: Drug: Propofol injection

Detailed Description

A. Preoperative settings:

In the anesthesia clinic, an informed written consent will be obtained from every patient one day before the surgery. All patients will be assessed preoperatively by careful history taking full physical examination, and laboratory evaluation.

B. Intraoperative settings:

On the arrival to operation room; standard ASA monitors will be attached automatic blood pressure measurements, five-lead ECG monitor, capnography and finger pulse oximetry will be applied, The baseline value was measured.

Measurement of mean arterial blood pressure by non-invasive blood pressure monitoring(NIBP) at selected time interval would be obtained as follows:

• baseline value( NIBP "systolic, diastolic and mean value" and HR): 1 minute pre-injection
• 1 minute post injection
• 3 minutes post injection
• 5 minutes post injection
• Final value :7 minutes post injection

The investigators will calculate the percentage difference of lowest mean arterial blood pressure from baseline value using the following formula:

(Baseline mean blood pressure - lowest value mean blood pressure)/ Baseline mean blood pressure

• An intravenous infusion of ringer acetate 3ml/kg will be started.
• Pre-oxygenation with 100% O2 on 8 L/min for 3 min via face mask will be started.

• Induction of anesthesia would be done by using propofol dosage according to the group

  1. Group LDP will receive 1.5mg/kg propofol during induction of anesthesia.
  2. Group HDP will receive 2.5mg/kg propofol during induction of anesthesia.
• In group LDP, if the patient is still showing signs of awareness or intact eyelash reflex within two minutes post injection, the investigators will add 1mg/kg propofol and the patient will be shifted to the HDP group.
• Fentanyl would be given during induction 2mic/kg IV.
• Atracurium besylate 0.5 mg/kg IV will be given to facilitate tracheal intubation, and anaesthesia will be maintained with 1 to 1.5% isoflurane.
• After orotracheal intubation, mechanical ventilation will be started, controlled mechanical ventilation will be achieved by tidal volumes of 8-10 mL/Kg and frequency of ventilation of up to 12-14 breaths/min to maintain normocapnia: end-tidal pressure CO2 (ET CO2) at the level of 35 ± 5 mm Hg and Positive End Expiratory Pressure (PEEP) of 5-10 cm H2O.
• Supplemental boluses of Atracurium besylate 0.1 mg/kg IV will be administered every 20 minutes to maintain muscle relaxation during surgery. Anaesthesia will be maintained with isoflurane 1-1.5% to maintain the HR and MAP within 20% of pre-induction values and/or Heart Rate (HR) < 85 beats/ min during surgical stimulation.
• Regular automated monitoring : NIBP "systolic, diastolic and mean value" and HR /5minutes
• At the end of the surgery, each patient will be extubated upon meeting the extubation criteria.
• Intraoperatively, any increase or decrease of HR, hypotension or hypertension will be managed as required.
• If the patient sustains Bradycardia (defined as: HR ≤50 bpm for 3 minutes), atropine 0.6 mg/kg increments will be administered till acceptable response.
• If the patient sustains Hypotension (defined as a decrease in systolic blood pressure >20%-30% of baseline value for 3 minutes), administration of ephedrine5-6 mg increments, and fast intravenous fluid bolus (250 ml crystalloids).
• If the patient sustains Hypertension (defined as an increase in systolic blood pressure >20%-30% of baseline value for 3 minutes ), raising the end-tidal isoflurane concentration to 2% and 0.5 μg/kg IV bolus of fentanyl will be administered till acceptable response after exclusion of causes other than sympathetic response to surgical stimulus .

• The whole study period will be attended and supervised by the most skilled person in the study group.

  c.Postoperative settings: The patients will be transferred to the post-anaesthesia care unit and will be put under observation.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hadeer s saied, MBBCH; Phone Number: +201021588208; Email: hadeer.saad@med.asu.edu.eg
• Study Contact Backup: Name: Hadeer S Saied, M.B.B.CH; Phone Number: +201021588208; Email: hadeer.saad@med.asu.edu.eg

Study Locations

• Egypt
  • Abbaseya
    • Cairo, Abbaseya, Egypt, 11517
      • Recruiting
      • Ain Shams University
      • Contact: hadeer s saied, MBBCH; Phone Number: +201021588208; Email: hadeer.saad@med.asu.edu.eg
      • Contact: hadeer s saied, MBBCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: from 21 years old till 40 years old.
2. Patients with ASA classification I and II.
3. Undergoing a scheduled elective surgery.

Exclusion Criteria:

1. Declining to give written informed consent.
2. ASA classification III-V.
3. Patients with class III (morbid) obesity or more (BMI >40 Kg/m2)
4. Patients with severe intraoperative hypotension requiring large volume of intravascular fluid treatment.
5. Severe or uncontrolled hypertension (NIBP> 150/100) , congestive heart failure, moderate to severe valvular heart disease , uncontrolled arrhythmia , heart rate>100bpm .
6. Significant hepatic or renal disorder.
7. Patients with uncontrolled diabetes mellitus type 1 or type 2(evidenced by autonomic dysfunction or organ complications, ischemic heart disease or cerebrovascular disease).
8. Patients who were pregnant (positive pregnancy test) or menstruating.
9. Anemia with hemoglobin level <9.0 g/dL
10. Hypersensitivity to soybean oil, egg lecithin, or glycerol.
11. Medical substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: high dose propofol during induction of anesthesia.; this group will be given high dose propofol 2.5mg/kg during induction of anesthesia.	Drug: Propofol injection; hemodynamic changes of a high dose versus low dose propofol during induction of anesthesia.
Active Comparator: low dose propofol during induction of anesthesia.; this group will be given low dose propofol 1.5mg/kg during induction of anesthesia.	Drug: Propofol injection; hemodynamic changes of a high dose versus low dose propofol during induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage difference of lowest mean arterial blood pressure from baseline value.	will	from injection till 7 minutes post-injection

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Hadeer S Saied, M.B.B.CH, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 19, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: FMASU MS332/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be shared once study is completed
• IPD Sharing Time Frame: before may 2025
• IPD Sharing Access Criteria: free
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No