Comparative analysis in dose requirement of propofol for induction of anaesthesia at varying time intervals after fentanyl administration - a Randomized clinical trial

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/07/043932
• Lead Sponsor: Chettinad Hospital and Research Institute

Brief Summary

**STUDY OBJECTIVE**

Primary Objective

To study the requirement of propofolfor induction immediately, 5 and 7 mins after fentanyl administration

 Secondary Objective

To compare post induction hemodynamicchanges, incidence of hypotension and fluid bolus requirement

To compare the incidence of movement,vocalization and additional propofol requirement

To compare incidence of apnea followinginduction

 **STUDY DESIGN** - Randomized Clinical Trial

 **INCLUSIONCRITERIA**

Adult patients aged between 18 and 65 years

ASA-I & II physical status

Elective procedures under general anaesthesia

  **EXCLUSIONCRITERIA**

Patient not willing to be in the study group

Contraindication to GA

ASA-III & IV physical status

BMI > 35 kg/m2

Anticipated difficult airway

Pregnant patients

History of allergy to study drug

Drug abuse including chronic alcoholics

Emergency procedures

 **METHODOLOGY**

1) All the patients will undergo routine pre-operative assessment in thepre-anaesthetic clinic.

2) Informed written consent will be obtained.

3) Patients will be randomized using a computer‑generated randomnumbers into one of the 3 groups

4) Patients will receive the premedication drugs Tab. Ranitidine 150mgand Tab. Alprazolam 0.5mg, night before surgery and in the morning of surgery.

5) On arrival to the operative room an IV access with 18 or 20 Gauge IVcannula will be secured.

6) In the operating room, standard preinduction monitors includingelectrocardiography, pulse oximetry, and noninvasive blood pressure will beattached and baseline heart rate and blood pressure will be recorded, followedby recordings at one‑minute intervals.

7) IV infusion with Ringer’s Lactate will be started at 10 ml/kg/hr andpreoxygenated with 100% of Oxygen (O2) for 3 minutes

8) Fentanyl 2 mcgs/kg TBW will be administered.

9) Group 1 – Patients will be administered with Propofol, immediatelyafter Fentanyl administration

10) Group 2 – Patients will be administered with Propofol, 5 min afterFentanyl administration

11) Group 3 – Patients will be administered with Propofol, 7 min afterFentanyl administration

12) Anaesthesiologist posted in the operating room will inject fentanyland the time will be noted

13) An independent anaesthesiologist will be called in to start propofolinjection using infusion pump according to group randomization.

14) The anaesthesiologist who administers propofol will start thepre-loaded propofol infusion at 300 ml/hr while communicating verbally with thepatient and will note the dose required to produce loss of verbal response.

15) After checking for adequate ventilation, the patients will receivemuscle relaxant – Inj. Atracurium 0.5mg/kg or Inj. Vecuronium 0.1mg/kg bodyweight IV.

16) In case of movement or vocalization, additional doses of  propofol in aliquots of 20 mg will beadministered and the total dose administered will be noted

17) Incidence of apnea will be recorded

18) Pulse rate (PR), Systolic BP (SBP), Diastolic BP (DBP), MeanArterial Pressure (MAP),and SpO2 will be noted every 2 minutes from fentanyladministration till induction of anaesthesia.

19) In case of hypotension following induction, IV bolus of 300 mlRinger’s lactate will be given.

20) Hypotension not responding to fluid bolus will be treated using IVPhenylephrine

21) Occurrence of hypotension, bradycardia, requirement of fluidboluses, vasopressors and apnea following induction will be recorded.

 **END POINT** - Loss of verbal response will be the endpoint ofinduction following propofol administration

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Study Completion: 2022-09-30
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Adult patients aged between 18 and 65 years 2) ASA-I & II physical status 3) Elective procedures under general anaesthesia.

Exclusion Criteria

1. Patient not willing to be in the study group 2) Contraindication to GA 3) ASA-III & IV physical status 4) BMI > 35 kg/m2 5) Anticipated difficult airway 6) Pregnant patients 7) History of allergy to study drug 8) Drug abuse including chronic alcoholics 9) Emergency procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the requirement of propofol for induction immediately, 5 and 7 mins after fentanyl administration	At baseline, 4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the incidence of movement, vocalization and additional propofol requirement	Soon after end of verbal response post induction

Trial Locations

Locations (1)

Chettinad Health and Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Chettinad Health and Research Institute

🇮🇳Chennai, TAMIL NADU, India

Dr Kannan

Principal investigator

9677211422

drkannansamuel@gmail.com