NCT07713134

Brief Summary

This study aimed to investigate the safety and efficacy of oliceridine compared with sufentanil in outpatient hysteroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

July 14, 2026

Last Update Submit

July 17, 2026

Conditions

HysteroscopyAnalgeisa

Outcome Measures

Primary Outcomes (3)

  • heart rate（beats per minute）

    before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery

  • mean arterial pressure(mmHg)

    before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery

  • proportion of participants with successful completion of office hysteroscopy procedure

    at the end of the hysteroscopy procedure

Secondary Outcomes (2)

  • number of participants with postoperative nausea and vomiting within 24 hours after surgery

    within 24 hours after surgery

  • number of Participants with Intraoperative Respiratory Depression

    from induction of anesthesia to completion of surgery

Study Arms (2)

sunfentanil

ACTIVE COMPARATOR

0.15μg/kg sufentanil was used as the analgic for patients undergoing office hysteroscopy

Drug: Sufentanil

oliceridine

EXPERIMENTAL

0.04mg/kg sufentanil was used as the analgic for patients undergoing office hysteroscopy

Drug: Oliceridine

Interventions

SufentanilDRUG

sufentanil is diluted to a 5μg/ml injection solution

sunfentanil
OliceridineDRUG

Oliceridine is diluted to a 1mg/kg injection solution

oliceridine

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • voluntary signing of the anesthesia informed consent form;
  • stable vital signs;
  • age between 18 and 60years;
  • American Society of Anesthesiologists (ASA) physical status I or II; and
  • body mass index (BMI) \<30 kg/m²

You may not qualify if:

  • inability or unwillingness to sign the informed consent form;
  • known allergy to the study drug;
  • uncontrolled hypertension or diabetes mellitus;
  • significant central nervous system disease;
  • diagnosed psychiatric disorders;
  • use of anxiolytics, antidepressants, hypnotics, or sedatives within the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangshan Maternal and Child Health Hospital, Tangshan, Hebei 063000

Tangshan, Hebei, China

Location

Related Publications (5)

  • Chen L, Xie K, Ji K, Long M, Zhang Y, He K. Effects of Oliceridine Versus Sufentanil on Hemodynamic Stability in Elderly Hypertensive Patients During Laryngeal Mask Airway Anesthesia: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Oct 22;19:9515-9522. doi: 10.2147/DDDT.S547901. eCollection 2025.

    PMID: 41147005BACKGROUND

  • Tan HS, Habib AS. Oliceridine: A Novel Drug for the Management of Moderate to Severe Acute Pain - A Review of Current Evidence. J Pain Res. 2021 Apr 14;14:969-979. doi: 10.2147/JPR.S278279. eCollection 2021.

    PMID: 33889018BACKGROUND

  • Yi K, Sun W, Yu W, Chen S. Overview and Prospects of the Clinical Application of Oliceridine. Drug Des Devel Ther. 2025 Jun 26;19:5415-5430. doi: 10.2147/DDDT.S525471. eCollection 2025.

    PMID: 40599606BACKGROUND

  • Lei X, Zhang T, Huang X. Comparison of a single intravenous infusion of alfentanil or sufentanil combined with target-controlled infusion of propofol for daytime hysteroscopy: a randomized clinical trial. Ther Adv Drug Saf. 2024 Oct 31;15:20420986241292231. doi: 10.1177/20420986241292231. eCollection 2024.

    PMID: 39493926BACKGROUND

  • Anggraeni TD, Widyatama A, Soetikno V, Davis GS, Setiaka HA, Sekarlangit MC. Efficacy of Oral Paracetamol Compared with Oral Ketoprofen for Pain Management in Office Hysteroscopy: A Double-Blind, Randomized Clinical Trial. Medicina (Kaunas). 2026 Jan 14;62(1):170. doi: 10.3390/medicina62010170.

    PMID: 41597456BACKGROUND

MeSH Terms

Interventions

Sufentanil((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 20, 2026

Study Start

August 1, 2025

Primary Completion

May 20, 2026

Study Completion

June 30, 2026

Last Updated

July 20, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)