Etomidate vs Propofol-Induction Characteristics

Hemodynamics Clinical Trial

— Induction  

Official title:

Comparison of Induction Characteristics of Two Anaesthetic Agents-Etomidate Lipuro and Propofol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807610
• Other study ID #: PS/IEC-HR/DISS/38
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2016
• Last updated: June 20, 2016
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: June 2016
• Source: Maharashtra University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The administration of a suitable drug by intravenous route for induction of anaesthesia has been an important component of anaesthetic management.The ability to deliver safe and effective anaesthesia with minimal side effects and rapid recovery is critically important to ensure safe and early discharge. An ideal intravenous (IV) anaesthetic agent should, have rapid onset, rapid recovery, be without undesirable cardiac and respiratory depression and lesser untoward effects like pain on injection, nausea, vomiting etc.No single drug is ideal.

Propofol (propofol 1%) has a smooth and rapid induction, rapid recovery, cerebro-protective effect but it causes hypotension, bradycardia, respiratory depression pain on injection.Etomidate is a hypnotic agent causing minimal histamine release and very stable hemodynamic profile. In the present study, investigators evaluated the induction characteristics and side effect profile of this newer lipid formulation of etomidate and compared it with propofol in same lipid formulation.

Material and Methods: Hundred ASA I & II patients in the age group 18-60 yrs, scheduled for dilatation and curettage procedure were randomly allocated in two groups based on induction agent Etomidate lipuro or Propofol.

Both groups received intravenous midazolam 0.02mg /kg and fentanyl 2 µg /kg as premedication. After induction with the desired agent titrated to bispectral index Entropy 40, the time to achieve BIS values to 40 (BIS 40 time) were measured. Heart rate, mean arterial pressures were recorded at baseline, induction and upto 10 minutes. Patients were asked for pain at the injection site, postoperative nausea and observed visually for myoclonus, apnea and thrombophlebitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I and II Female patients

• Elective Medical Termination of Pregnancy (MTP) surgery

Exclusion Criteria:

• Hemo-dynamically unstable patients

• Allergic to egg protein

• Patients with epilepsy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Hemodynamics
• Side Effects

Intervention

Drug:
• Inj Etomidate
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.
• Injection Propofol
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
• Placebo for Propofol
After premedication with IV midazolam 0.2mg/kg and IV Fentanyl 2ug/kg Placebo was given.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maharashtra University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	No
Secondary	Side effects of the drugs in the form of Pain on injection	0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. 0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. 0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. Pain on injection was measured using scale as 0 no pain,1verbal complaint to pain,2 withdrawal of arm,3 both verbal complaint and withdrawal of arm	2 minutes after injection of study drug.	No
Secondary	Myoclonic movements	Using Myoclonus scale as 0.No myoclonic movement. I. Minor myoclonic movement. II. Moderate myoclonic movement. III. Major myoclonic	60 seconds after injection of study drug	No
Secondary	Thrombophlebitis	Presence or absence of inflammation of vein through which the drug was injected.	24 hours postoperatively	No