Etomidate vs Propofol-Induction Characteristics

NCT02807610 | Completed Phase 4 DMC

• 1 other identifier: PS/IEC-HR/DISS/38
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ideal induction agent for day care surgery should have properties of rapid, smooth induction, better haemodynamic profile, faster recovery and devoid of side effects in the form of pain on injection, involuntary movements, respiratory depression and post-operative nausea/vomiting. Propofol is the drug being used for day care surgeries because of its rapid, smooth induction and faster recovery. But its use is associated with pain on injection (even with added lidocaine), hypotension and respiratory depression. So the need for an agent with better hemodynamic control and lesser side effects was felt. The introduction of etomidate lipuro revolutionised the anaesthesia practice. It possesses many of the properties of an ideal induction agent. This newer formulation of etomidate in lipid emulsion i.e. etomidate lipuro is known to have rapid, smooth induction, haemodynamic stability and lesser side effects than older etomidate with propylene glycol (hypnomidate). Hence, investigators devised a prospective randomized controlled open trial and compared this newer lipid formulation of etomidate with propofol in terms of - induction time, haemodynamic parameters and side effect profile.

Conditions

Hemodynamics; Side Effects

Keywords

Etomidate lipuro; Induction characteristics

Outcome Measures

Primary Outcomes (2)

• Heart rate per minute

  Mean of Heart rate per minute at above mentioned time intervals was measured and any study drug causing bradycardia (Heart rate \<50 was noted .

  Change in Heart rate per minute from baseline value every five minutes for 30 minutes.

• Mean Arterial Pressure

  Mean value of Mean Arterial Pressures(Summation of MAP divided by number of patients) at above mentioned time intervals was noted and study drug causing Hypotension(MAP\< 90mm of Hg) was noted.

  Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes

Secondary Outcomes (3)

• Side effects of the drugs in the form of Pain on injection

  2 minutes after injection of study drug.

• Myoclonic movements

  60 seconds after injection of study drug

• Thrombophlebitis

  24 hours postoperatively

Study Arms (2)

IV Propofol and IV Etomidate lipuro

EXPERIMENTAL

After premedication with IV midazolam 0.2mg kg-1, IV Fentanyl 2ug kg-1, Group P Patients received IV Propofol 2mg kg-1 slowly over 60 seconds till Entropy of 40 as a comparator agent in patients undergoing Medical termination of pregnancy(MTP) and Group ' E' Patients received IV Etomidate Lipuro 0.3mg kg-1 slowly over 60 seconds till Entropy of 40 as intervention agent in patients undergoing MTP

Drug: Inj Etomidate; Drug: Injection Propofol

IV Etomidate Lipuro and Placebo

ACTIVE COMPARATOR

After premedication with IV midazolam 0.2mg kg-1, IV Fentanyl 2ug kg-1, Group ' E' Patients received IV Etomidate Lipuro 0.3mg kg-1 slowly over 60 seconds till Entropy of 40 as intervention agent in patients undergoing MTP and placebo group received normal saline

Drug: Inj Etomidate; Drug: Placebo for Propofol

Interventions

Inj Etomidate DRUG

Induction of anesthesia using IV Etomidate 0.3mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0'.2mg kg-1 and IV Fentanyl 2ug kg-1.

Also known as: Etomidate Lipuro

IV Etomidate Lipuro and Placebo; IV Propofol and IV Etomidate lipuro

Injection Propofol DRUG

Induction of anesthesia using IV Propofol 2mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0.2mg kg-1 and IV Fentanyl 2ug kg-1

IV Propofol and IV Etomidate lipuro

Placebo for Propofol DRUG

After premedication with IV midazolam 0.2mg/kg and IV Fentanyl 2ug/kg Placebo was given.

IV Etomidate Lipuro and Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I and II Female patients
• Elective Medical Termination of Pregnancy (MTP) surgery

You may not qualify if:

• Hemo-dynamically unstable patients
• Allergic to egg protein
• Patients with epilepsy

Sponsors & Collaborators

• Maharashtra University of Health Sciences: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 21, 2016
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share