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

Diansan Su

Status: Enrolling

Conditions: Infertility Assisted Reproductive Technology; Infertility; Hypoxia

Treatments: Drug: remimazolam-alfentanil combination; Drug: propofol-alfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT07335536

ZJU2025C086

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

propofol-alfentanil

Active Comparator group

Description:

Sedation using remimazolam-alfentanil

Treatment:

Drug: propofol-alfentanil

remimazolam-alfentanil

Experimental group

Description:

Sedation using remimazolam-alfentanil

Treatment:

Drug: remimazolam-alfentanil combination