EP Intravenous Anesthesia in Hysteroscopy

NCT05259787 | Completed Phase 4 DMC

• 1 other identifier: EP hysteroscopy
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

propofol; etomidate; intravenous anesthesia; hysteroscopic surgery

Outcome Measures

Primary Outcomes (2)

• Modified observer's assessment of alert /sedation scores (MOAAS scores)

  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

  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 Outcomes (4)

• Incidence of manual ventilation intervention

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Pulse oxygen saturation (SpO2)

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Blood Pressure(BP)

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

• Heart rate (HR)

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Study Arms (2)

Etomidate combined with propofol（EP）

EXPERIMENTAL

0.2ml/kg IV

Drug: Sedation Etomidate combined with propofol

Propofol（P）

ACTIVE COMPARATOR

0.2ml/kg IV

Drug: Sedation Propofol

Interventions

Sedation Etomidate combined with propofol DRUG

Drug IV within 10 second during anesthesia induction.

Also known as: EP

Etomidate combined with propofol（EP）

Sedation Propofol DRUG

Drug IV within 10 second during anesthesia induction.

Also known as: EP

Propofol（P）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Diansan Su, MD,PHD

  Renji Hospital, Shanghai Jiaotong University, School of Medcine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: March 2, 2022
• Study Start: September 28, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 28, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)