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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
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.
Dongyang People's Hospital
Dongyang, Zhejiang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGLishui People's Hospital
Lishui, Zhejiang, China
NOT_YET_RECRUITINGIncidence 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
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