The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial.
Diansan Su
400 participants
Oct 20, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria6
- 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
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Interventions
Administer 7 μg/kg of fentanyl first，then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion.
Administer 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07335536