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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorDiansan Su

About this trial

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 criteria

Qualifiers

Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval

Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II

Disqualifiers

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

Trial design

Treatments tested in this trial

  • remimazolam-alfentanil combination
  • propofol-alfentanil

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Diansan Su

Lead sponsor

Zhejiang University

Sponsor institution