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NCT Number: NCT02807610

Etomidate vs Propofol-Induction Characteristics

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.

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Key information

Conditions

Hemodynamics Side Effects

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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

Placebo for Propofol

Drug

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

Primary outcomes

  1. Heart rate per minute

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

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

  2. Mean Arterial Pressure

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

    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.

Secondary outcomes

  1. Side effects of the drugs in the form of Pain on injection

    Time frame: 2 minutes after injection of study drug.

    • 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. Myoclonic movements

    Time frame: 60 seconds after injection of study drug

    Using Myoclonus scale as 0.No myoclonic movement. I. Minor myoclonic movement. II. Moderate myoclonic movement. III. Major myoclonic

  3. Thrombophlebitis

    Time frame: 24 hours postoperatively

    Presence or absence of inflammation of vein through which the drug was injected.

Sponsors and collaborators

Lead sponsor

Maharashtra University of Health Sciences

Other

Registry information

Official study title

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

Acronym: Induction

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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