The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial.

January 1, 2026 updated by: Diansan Su
Hypoxia is the most common adverse reaction during sedation outside the operating room.Exploring novel drug combinations to reduce the incidence of hypoxia during sedation in patients undergoing transvaginal oocyte retrieval procedures enhances patient safety and lowers perioperative adverse event rates. This multicenter, prospective, randomized, controlled clinical study will compare the hypoxia incidence rate of the remimazolam-alfentanil combination against the commonly used propofol-alfentanil combination.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Dongyang, Zhejiang, China, 322100
        • Not yet recruiting
        • Dongyang People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Lishui, Zhejiang, China, 323000
        • Not yet recruiting
        • Lishui People's Hospital
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval
  • Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

  • Subjects with contraindications to general anesthesia, acute or severe cardiovascular disease history, acute upper respiratory infection, chronic obstructive pulmonary disease (COPD), asthma attacks, or uncontrolled hypertension
  • Subjects with alcohol abuse
  • Subjects with severe hepatic or renal insufficiency, severe cardiovascular disease, or psychiatric disorder history
  • Subjects with hearing impairment preventing communication
  • Subjects with a history of long-term sedative or opioid use, or allergies to benzodiazepines, flumazenil, opioids and their antidotes, propofol, eggs, or soy products
  • Subjects with SpO2 < 95% while breathing room air after entering the room

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol-alfentanil
Sedation using remimazolam-alfentanil
Drug: propofol-alfentanil
Administer 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.
Experimental: remimazolam-alfentanil
Sedation using remimazolam-alfentanil
Drug: remimazolam-alfentanil combination
Administer 7 μg/kg of fentanyl first，then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
SpO₂ between 75% and 89% with duration <60 seconds
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of subclinical respiratory depression
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
90% ≤ SpO₂ < 95%
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Proportion of hypoxic correction measures
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Corrective measures for hypoxia should be implemented in the following sequence: increase oxygen flow rate, perform jaw thrust, administer positive pressure ventilation via a face mask, insert a nasopharyngeal airway while performing jaw thrust, and proceed to endotracheal intubation or mechanical ventilation with a laryngeal mask until SpO₂ reaches ≥95%.
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of other adverse events
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Collaborators and Investigators

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

Sponsor

Diansan Su

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 20, 2025

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

January 1, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2025C086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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