Etomidate Induction in Hysteroscopic Surgery

Study Overview
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Brief Summary
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This study intends to study the optimal dose induced by etomidate in outpatients undergoing painless hysteroscopic surgery. At present, the dosage in the user manual is 0.1-0.3mg/kg. In clinical use, it is found that 0.1mg/kg often fails to achieve sedative effect, and 0.3mg/kg is prone to muscle twitching. Therefore, three groups of doses of 0.15mg/kg, 0.2mg/kg and 0.25mg/kg are set. It is hoped that this study will provide a basis for clinical evaluation of etomidate in anesthesia induction of hysteroscopic surgery.

Official Title
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Randomized Controlled Study of Etomidate Induction in Hysteroscopic Surgery

Conditions
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Etomidate Induced Dose, Hysteroscopic Surgery

Intervention / Treatment
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* Drug: etomidate
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients to undergo hysteroscopic surgery Exclusion Criteria: Hemo-dynamically unstable patients Allergic to egg protein Patients with epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eto 0.15mg/kg<br>Etomidate 0.15mg/kg for anesthesia induction | Drug: etomidate<br>* use etomidate for anesthesia induction in hysteroscopic surgery<br>|
| Experimental: Eto 0.2mg/kg<br>Etomidate 0.2mg/kg for anesthesia induction | Drug: etomidate<br>* use etomidate for anesthesia induction in hysteroscopic surgery<br>|
| Experimental: Eto 0.25mg/kg<br>Etomidate 0.25mg/kg for anesthesia induction | Drug: etomidate<br>* use etomidate for anesthesia induction in hysteroscopic surgery<br>|
| Active Comparator: Propofol 2mg/kg<br>propofol 2mg/kg for anesthesia induction | Drug: propofol<br>* use propofol for anesthesia induction in hysteroscopic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Pressure | Mean value of Mean Arterial Pressures | Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes | 
| Heart rate per minute | Mean of Heart rate per minute at above mentioned time intervals was measured and any study drug causing bradycardia | Change in Heart rate per minute from baseline value every five minutes for 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoclonic movements | % of cases with Myoclonic movements | 60 seconds after injection of study drug | 
| Post Operative Nausea and Vomiting | % of cases with any treatment for Post Operative Nausea and Vomiting | Throughout entire study estimated to take 1 month to complete | 
| any oxygen saturation event below 85% by pulse oximetry | % of cases with any oxygen saturation event below 85% by pulse oximetry | Throughout entire study estimated to take 1 month to complet |