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Recruiting NCT07335536

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

No phase Interventional Hypoxia Infertility Infertility Assisted Reproductive Technology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: remimazolam-alfentanil combination, propofol-alfentanil.
Who it may be relevant to
Registry conditions: Hypoxia, Infertility, Infertility Assisted Reproductive Technology. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of Hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcome measures (3)
  • Incidence of severe hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
  • Incidence of subclinical respiratory depression [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
  • Proportion of hypoxic correction measures [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 3 centers
  • Dongyang People's Hospital — Dongyang
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • Lishui People's Hospital — Lishui

Publications

  • Zhang F, Chang H, Qing W, Yu R, Liao Q, Tong J. Remimazolam Tosylate Combined with Low-Dose Propofol Improves Sedation and Safety in Hysteroscopy. Drug Des Devel Ther. 2022 Nov 29;16:4101-4108. doi: 10.2147/DDDT.S390403. eCollection 2022. PMID 36471692

Identifiers

NCT: NCT07335536 · ZJU2025C086

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗