The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial.
NCT07335536 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2026-01-13
Summary
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.
Conditions
- Hypoxia
- Infertility
- Infertility Assisted Reproductive Technology
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Diansan Su
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-20
- Primary Completion
- 2026-12-20
- Completion
- 2026-12-30
Countries
- China
Study Locations
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