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.
Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval
Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II
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
Parallel
remimazolam-alfentanil combination
DrugAdminister 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
DrugAdminister 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.
Incidence of Hypoxia
SpO₂ between 75% and 89% with duration \<60 seconds
Incidence of severe hypoxia
SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
Incidence of subclinical respiratory depression
90% ≤ SpO₂ \< 95%
Proportion of hypoxic correction measures
Corrective measures for hypoxia should be implemented in the following sequence: increase oxygen flow rate, perform jaw thrust, administer positive pressure ventilation via a face mask, insert a nasopharyngeal airway while performing jaw thrust, and proceed to endotracheal intubation or mechanical ventilation with a laryngeal mask until SpO₂ reaches ≥95%.
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
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Diansan Su
Lead sponsor
Zhejiang University
Sponsor institution
