NCT07335536

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

September 22, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

October 20, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

September 22, 2025

Last Update Submit

January 1, 2026

Conditions

HypoxiaInfertilityInfertility Assisted Reproductive Technology

Keywords

Hypoxiaoocyte retrievalremimazolamgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Hypoxia

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

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

Secondary Outcomes (3)

  • Incidence of severe hypoxia

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

  • Incidence of subclinical respiratory depression

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

  • Proportion of hypoxic correction measures

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

Other Outcomes (1)

  • The incidence of other adverse events

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

Study Arms (2)

propofol-alfentanil

ACTIVE COMPARATOR

Sedation using remimazolam-alfentanil

Drug: propofol-alfentanil

remimazolam-alfentanil

EXPERIMENTAL

Sedation using remimazolam-alfentanil

Drug: remimazolam-alfentanil combination

Interventions

remimazolam-alfentanil combinationDRUG

Administer 7 μg/kg of fentanyl first，then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion.

remimazolam-alfentanil
propofol-alfentanilDRUG

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

propofol-alfentanil

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval
  • Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dongyang People's Hospital

Dongyang, Zhejiang, 322100, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Lishui People's Hospital

Lishui, Zhejiang, 323000, China

NOT YET RECRUITING

Related Publications (1)

  • 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: 36471692BACKGROUND

MeSH Terms

Conditions

HypoxiaInfertility

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Central Study Contacts

Diansan Su, Dr.

CONTACT

+86-18616514088diansansu@yahoo.com

Shuhan Gu, MD.

CONTACT

+86-13515813047shuhangu@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Anesthesiology

Study Record Dates

First Submitted

September 22, 2025

First Posted

January 13, 2026

Study Start

October 20, 2025

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

CN(3)