Remimazolam to reduce hypoxia during sedated transvaginal oocyte retrieval

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

We will test if remimazolam plus alfentanil lowers the chance of low oxygen compared with propofol plus alfentanil in women having sedated transvaginal oocyte retrieval.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Zhejiang University (other)
• Locations: 3 sites (Dongyang, Zhejiang and 2 other locations)
• Trial ID: NCT07335536 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized controlled study will enroll women aged 18–50 undergoing painless transvaginal oocyte retrieval at three hospitals in Zhejiang, China. Participants with ASA physical status I–II will be randomized to receive either remimazolam-alfentanil or propofol-alfentanil for sedation. The primary outcome is the incidence of hypoxia during the procedure, and perioperative adverse events and safety measures will be recorded. Key exclusions include significant cardiopulmonary disease, uncontrolled hypertension, severe hepatic or renal insufficiency, baseline SpO2 <95% on room air, and known allergies to the study drugs.

Who should consider this trial

Good fit: Ideal candidates are women aged 18–50 with ASA physical status I–II planning painless transvaginal oocyte retrieval who do not have major cardiopulmonary, hepatic, renal issues or relevant drug allergies.

Not a fit: Patients with active respiratory disease (including COPD or recent asthma attacks), uncontrolled cardiovascular conditions, severe hepatic or renal insufficiency, baseline SpO2 <95% on room air, or known allergies to benzodiazepines, propofol, alfentanil, or related agents may not benefit and are excluded.

Why it matters

Potential benefit: If successful, using remimazolam could reduce low-oxygen events during sedation and improve patient safety during oocyte retrieval.

How similar studies have performed: Remimazolam has shown favorable sedation and respiratory safety profiles compared with propofol in other procedural sedation settings, but its specific use in oocyte retrieval is less well studied.

Eligibility criteria

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

Where this trial is running

Dongyang, Zhejiang and 2 other locations

• Dongyang People's Hospital — Dongyang, Zhejiang, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• Lishui People's Hospital — Lishui, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Diansan Su, Dr.

Conditions: Hypoxia, Infertility, Infertility Assisted Reproductive Technology, oocyte retrieval, remimazolam, general anesthesia