EP Intravenous Anesthesia in Hysteroscopy

November 13, 2022 updated by: RenJi Hospital

Efficacy and Safety of Etomidate Combined With Propofol Intravenous Anesthesia During Hysteroscopic Procedures: a Randomized Controlled Trial

Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. Propofol is one of the most commonly used intravenous anesthetics in clinic for hysteroscopic procedures, however high dose propofol bring some potential clinical safety hazards.In this study, the feasibility and safety of Etomidate combined with propofol(1:2) as improved scheme for hysteroscopic surgery will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. For hysteroscopic surgery using bipolar resectoscopes, hysteroscopic morcellators or shavers, it is considered efficient and safe to be performed under general anaesthesia, such as intravenous anesthesia. Propofol is one of the most commonly used intravenous anesthetics in clinic, however high dose propofol bring some potential clinical safety hazards, reducing respiratory rate and tidal volume, causing apnea or hypoxemia, and leading to hypoxia especially for obese and elderly patients. Propofol combined with etomidate as an improved scheme of intravenous anesthesia has been proved to have advantages in gastroendoscopy.In this study, the patients undergoing elective hysteroscopic surgery will be randomly assigned to two groups of intravenous anesthesia: Etomidate combined with propofol of 1:2 ratio (EP) versus Propofol (P). The sedation degree, respiratory related events (hypoxia, asphyxia incidence and maintenance time) and hemodynamic events，integrated pulmonary index (IPI) of the two groups will be evaluated to explore the feasibility and safety of the clinical application of EP mixture in hysteroscopic surgery.

Study Type

Interventional

Enrollment (Anticipated)

366

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Elective hysteroscopic surgery;
  • intravenous anesthesia;
  • normal reading and understanding ability
  • volunteer to participate

Exclusion Criteria:

  • serious complications such as heart failure, liver failure, pulmonary dysfunction, renal failure, etc.
  • predictable difficult airway
  • high risk of reflux aspiration
  • allergy to propofol or etomidate
  • already participated in other clinical trials within three months before admission
  • unwilling to cooperate

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Etomidate combined with propofol（EP）
0.2ml/kg IV
Drug: Sedation Etomidate combined with propofol
Drug IV within 10 second during anesthesia induction.
Other Names:
  • EP
ACTIVE_COMPARATOR: Propofol（P）
0.2ml/kg IV
Drug: Sedation Propofol
Drug IV within 10 second during anesthesia induction.
Other Names:
  • EP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified observer's assessment of alert /sedation scores (MOAAS scores)
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Modified observer's assessment of alert /sedation score 0-2 as effective anesthesia for hysteroscopic procedures.The MOAAS scores is a 6-point scale that assesses the responsiveness of patients and coincides with the ASA continuum of sedation. A patient with a score of 5 responds readily to name spoken in a normal tone, 4 lethargic response to name spoken in a normal tone, 3 responds only after the name is called loudly and/or repeatedly, 2 responds only after mild prodding or shaking, 1 responds only after painful trapezius squeeze, and 0 does not respond to painful trapezius squeeze (0 to 1 deep sedation, 2 to 4 moderate sedation, and 5 minimal sedation or alert).
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Apnea duration
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The time duration from the disappearance to the recovery of spontaneous breathing, record in seconds.
Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of manual ventilation intervention
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
When Pulse Oxygen Saturation(SpO2)<90% ，mask pressure ventilation or mechanical ventilation should be used as the intervention. The intervention incidence will be record in percentage.
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Pulse oxygen saturation (SpO2)
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Pulse oxygen saturation (SpO2) will be recorded in percentage, range from 0 to 100%.
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Blood Pressure(BP)
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Noninvasive blood pressure will be recorded in mmHg.
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Heart rate (HR)
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Heart rate (HR) will be recorded in times/min.
Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Study Director: Diansan Su, MD,PHD, Renji Hospital, Shanghai Jiaotong University, School of Medcine

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 (ACTUAL)

September 28, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

February 28, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP hysteroscopy

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 Anesthesia

Clinical Trials on Sedation Etomidate combined with propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe