Etomidate Induction in Hysteroscopic Surgery

NCT05520645 | Unknown

• 1 other identifier: 89476
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Etomidate Induced Dose; Hysteroscopic Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Myoclonic movements

  60 seconds after injection of study drug

• Post Operative Nausea and Vomiting

  Throughout entire study estimated to take 1 month to complete

• any oxygen saturation event below 85% by pulse oximetry

  Throughout entire study estimated to take 1 month to complet

Study Arms (4)

Eto 0.15mg/kg

EXPERIMENTAL

Etomidate 0.15mg/kg for anesthesia induction

Drug: etomidate

Eto 0.2mg/kg

EXPERIMENTAL

Etomidate 0.2mg/kg for anesthesia induction

Drug: etomidate

Eto 0.25mg/kg

EXPERIMENTAL

Etomidate 0.25mg/kg for anesthesia induction

Drug: etomidate

Propofol 2mg/kg

ACTIVE COMPARATOR

propofol 2mg/kg for anesthesia induction

Drug: propofol

Interventions

etomidate DRUG

use etomidate for anesthesia induction in hysteroscopic surgery

Eto 0.15mg/kg; Eto 0.25mg/kg; Eto 0.2mg/kg

propofol DRUG

use propofol for anesthesia induction in hysteroscopic surgery

Propofol 2mg/kg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients to undergo hysteroscopic surgery

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Interventions

Etomidate; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 30, 2022
• Study Start: August 25, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share