Etomidate Induction in Hysteroscopic Surgery

Hysteroscopic Surgery Clinical Trial

Official title:

Randomized Controlled Study of Etomidate Induction in Hysteroscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05520645
• Other study ID #: 89476
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Patients to undergo hysteroscopic surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hysteroscopic Surgery

Intervention

Drug:
• etomidate
use etomidate for anesthesia induction in hysteroscopic surgery
• propofol
use propofol for anesthesia induction in hysteroscopic surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Myoclonic movements	% of cases with Myoclonic movements	60 seconds after injection of study drug
Secondary	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
Secondary	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