An interventional study of remimazolam-alfentanil combination and propofol-alfentanil in Hypoxia, Infertility and Infertility Assisted Reproductive Technology, sponsored by Diansan Su. Recruiting at 3 sites in China. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Diansan Su · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Sedation using remimazolam-alfentanil
Drug: propofol-alfentanil
Sedation using remimazolam-alfentanil
Drug: 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.
Administer 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
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of severe hypoxia
SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of subclinical respiratory depression
90% ≤ SpO₂ \< 95%
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
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%.
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Plan to share: Undecided
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Diansan Su