EP Intravenous Anesthesia in Hysteroscopy

NCT ID: NCT05259787

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2023-12-30

Brief Summary

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.

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Etomidate combined with propofol（EP）

0.2ml/kg IV

Group Type: EXPERIMENTAL

Sedation Etomidate combined with propofol

Intervention Type: DRUG

Drug IV within 10 second during anesthesia induction.

Propofol（P）

0.2ml/kg IV

Group Type: ACTIVE_COMPARATOR

Sedation Propofol

Intervention Type: DRUG

Drug IV within 10 second during anesthesia induction.

Interventions

Sedation Etomidate combined with propofol

Drug IV within 10 second during anesthesia induction.

Intervention Type: DRUG

Sedation Propofol

Drug IV within 10 second during anesthesia induction.

Intervention Type: DRUG

Other Intervention Names

EP; EP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diansan Su, MD,PHD

Role: STUDY_DIRECTOR

Renji Hospital, Shanghai Jiaotong University, School of Medcine

Locations

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EP hysteroscopy

Identifier Type: -

Identifier Source: org_study_id