Etomidate vs Propofol-Induction Characteristics
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2016 |
| First Submitted: | 06/08/2016 |
| Estimated Enrollment Submitted: | 06/19/2016 |
| First Posted: | 06/20/2016 |
| Last Update Submitted: | 06/19/2016 |
| Last Update Posted: | 06/20/2016 |
| Actual Study Start Date: | 02/28/2011 |
| Estimated Primary Completion Date: | 03/31/2013 |
| Estimated Study Completion Date: | 03/31/2013 |
Condition or disease
Intervention/treatment
Drug: Inj Etomidate
Drug: IV Propofol and IV Etomidate lipuro
Drug: IV Etomidate Lipuro and Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: IV Propofol and IV Etomidate lipuro 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: IV Propofol and IV Etomidate lipuro 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 |
| Active Comparator: IV Etomidate Lipuro and Placebo 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: IV Etomidate Lipuro and Placebo After premedication with IV midazolam 0.2mg/kg and IV Fentanyl 2ug/kg Placebo was given. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Heart rate per minute [Change in Heart rate per minute from baseline value every five minutes for 30 minutes.]
2. Mean Arterial Pressure [Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes]
Secondary Outcome Measures
1. Side effects of the drugs in the form of Pain on injection [2 minutes after injection of study drug.]
2. Myoclonic movements [60 seconds after injection of study drug]
3. Thrombophlebitis [24 hours postoperatively]
