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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-20

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoxia Infertility Infertility Assisted Reproductive Technology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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propofol-alfentanil

Sedation using remimazolam-alfentanil

Group Type ACTIVE_COMPARATOR

propofol-alfentanil

Intervention Type DRUG

Administer 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.

remimazolam-alfentanil

Sedation using remimazolam-alfentanil

Group Type EXPERIMENTAL

remimazolam-alfentanil combination

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No