Etomidate Induction in Hysteroscopic Surgery

August 29, 2022 updated by: Peking University Third Hospital

Randomized Controlled Study of Etomidate Induction in Hysteroscopic Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Patients to undergo hysteroscopic surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes
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
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
Time Frame: 60 seconds after injection of study drug
% of cases with Myoclonic movements
60 seconds after injection of study drug
Post Operative Nausea and Vomiting
Time Frame: Throughout entire study estimated to take 1 month to complete
% 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
Time Frame: Throughout entire study estimated to take 1 month to complet
% of cases with any oxygen saturation event below 85% by pulse oximetry
Throughout entire study estimated to take 1 month to complet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 25, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hysteroscopic Surgery

Clinical Trials on etomidate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe