A study to compare two different dose-combinations of Propofol(Induction agent)and Ketamine(Induction agent)(Ketofol) as induction agent for patients undergoing surgery under general anaesthesia.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/06/025990
• Lead Sponsor: Government Mohan Kumaramangalam Medical College and Hospital

Brief Summary

Patients under going elective surgical procedure under general anaesthesia will be divided into two groups. Group A will be induced with Propofol 1.5 milligrams per kilogram with Ketamine 0.5 milligrams per kilogram and Group B with Propofol 1 milligram per kilogram with Ketamine 1 milligram per kilogram. The primary observation will be BIS values at various intervals, Time to loss of verbal contact and Time to loss of eye lash reflex. The secondary observation will be Hemodynamic parameters like Systolic blood pressure, Diastolic blood pressure, Mean arterial blood pressure and Heart rate.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-05-20
• Study Start: 2020-06-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

American Society of Anaesthesiologists- Physical status 1 and 2 Patients undergoing elective surgical procedure requiring Endotracheal intubation.

Exclusion Criteria

History of Cardiovascular of neurological disease Pregnancy Psychiatric disorders Contraindication or allergies to propofol or ketamine Emergency surgeries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BIS values at various intervals	Eleven time points: Time 1, BIS at baseline; Time 2, Time at loss of verbal contact; Time 3, BIS at 5 seconds after loss of verbal contact; Time 4, Time at loss of eye lash reflex; Time 5, BIS at 5 seconds after loss of eyelash reflex; Time 6, BIS at 2 minutes after induction; Time 7, BIS before intubation; Time 8,BIS after intubation; Time 9, BIS at 5 minutes; Time 10, BIS at 10 minutes; Time 11, BIS at 20 minutes
Time for loss of verbal contact	Eleven time points: Time 1, BIS at baseline; Time 2, Time at loss of verbal contact; Time 3, BIS at 5 seconds after loss of verbal contact; Time 4, Time at loss of eye lash reflex; Time 5, BIS at 5 seconds after loss of eyelash reflex; Time 6, BIS at 2 minutes after induction; Time 7, BIS before intubation; Time 8,BIS after intubation; Time 9, BIS at 5 minutes; Time 10, BIS at 10 minutes; Time 11, BIS at 20 minutes
Time for loss of eye lash reflex	Eleven time points: Time 1, BIS at baseline; Time 2, Time at loss of verbal contact; Time 3, BIS at 5 seconds after loss of verbal contact; Time 4, Time at loss of eye lash reflex; Time 5, BIS at 5 seconds after loss of eyelash reflex; Time 6, BIS at 2 minutes after induction; Time 7, BIS before intubation; Time 8,BIS after intubation; Time 9, BIS at 5 minutes; Time 10, BIS at 10 minutes; Time 11, BIS at 20 minutes

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	Diastolic Blood Pressure

Trial Locations

Locations (1)

Government Mohan Kumaramangalam Medical College and Hospital; 🇮🇳 Salem, TAMIL NADU, India

Government Mohan Kumaramangalam Medical College and Hospital

🇮🇳Salem, TAMIL NADU, India

Dr G Manjeth kumar

Principal investigator

9500927199

manjeth@gmail.com