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NCT Number: NCT07335536

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

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Key information

Conditions

Hypoxia Genital Diseases Infertility Infertility Assisted Reproductive Technology Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dongyang People's Hospital, Dongyang, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

remimazolam-alfentanil combination

Drug

Administer 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

Drug

Administer 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.

Primary outcomes

  1. Incidence of Hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    SpO₂ between 75% and 89% with duration <60 seconds

Secondary outcomes

  1. Incidence of severe hypoxia

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s

  2. Incidence of subclinical respiratory depression

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    90% ≤ SpO₂ < 95%

  3. Proportion of hypoxic correction measures

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    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%.

Other outcomes

  1. The incidence of other adverse events

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su, Dr.

CONTACT

[email protected]

+86-18616514088

Shuhan Gu, MD.

CONTACT

[email protected]

+86-13515813047

Sponsors and collaborators

Lead sponsor

Diansan Su

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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