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

Sponsor
Diansan Su
Study ID
NCT07335536
Status
Recruiting
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Conditions

  • Hypoxia
  • Infertility
  • Infertility Assisted Reproductive Technology

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • remimazolam-alfentanil combination — DRUG
    Administer 7 μg/kg of fentanyl first，then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion.
  • propofol-alfentanil — DRUG
    Administer 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.

Study Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Oct 20, 2025
Status verified
Jan 2026
Primary completion
Dec 20, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: propofol-alfentanil
    Sedation using remimazolam-alfentanil
  • Experimental: remimazolam-alfentanil
    Sedation using remimazolam-alfentanil

Primary Outcome Measure

Incidence of Hypoxia [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours ]

Central Contacts

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