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CompletedNCT07713134Updated Jul 20, 2026

Comparison of the Efficacy and Safety of Oliceridine and Sufentanil in Patients Undergoing Outpatient Hysteroscopy

An interventional study of Sufentanil and Oliceridine in Hysteroscopy and Analgeisa, sponsored by Tangshan Maternal and Child Health Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Tangshan Maternal and Child Health Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Hysteroscopy
  • Analgeisa
03

In context

Lead sponsor

Tangshan Maternal and Child Health Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. inability or unwillingness to sign the informed consent form;
  2. known allergy to the study drug;
  3. uncontrolled hypertension or diabetes mellitus;
  4. significant central nervous system disease;
  5. diagnosed psychiatric disorders;
  6. use of anxiolytics, antidepressants, hypnotics, or sedatives within the past three months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
225 participants (actual)

Study arms

  • Active comparator
    sunfentanil

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

    Drug: Sufentanil

  • Experimental
    oliceridine

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

    Drug: Oliceridine

Interventions

  • DrugSufentanil

    sufentanil is diluted to a 5μg/ml injection solution

  • DrugOliceridine

    Oliceridine is diluted to a 1mg/kg injection solution

06

What researchers measure

Primary outcomes

  1. heart rate（beats per minute）

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

  2. mean arterial pressure(mmHg)

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

  3. proportion of participants with successful completion of office hysteroscopy procedure

    Time frame: at the end of the hysteroscopy procedure

Secondary outcomes

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

    Time frame: within 24 hours after surgery

  2. number of Participants with Intraoperative Respiratory Depression

    Time frame: from induction of anesthesia to completion of surgery

07

Study locations

1 site
  • Tangshan Maternal and Child Health Hospital, Tangshan, Hebei 063000
    Tangshan, Hebei, China
08

References and documents

Publications

  • 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. PubMed 41147005 ↗
  • 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. PubMed 33889018 ↗
  • 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. PubMed 40599606 ↗
  • 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. PubMed 39493926 ↗
  • 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. PubMed 41597456 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07713134
Lead sponsor
Tangshan Maternal and Child Health Hospital
Responsible party
Yu Zhang (principle investigator, Tangshan Maternal and Child Health Hospital) — Principal investigator
First posted
Jul 20, 2026
Start date
Aug 1, 2025
Primary completion
May 20, 2026
Completion
Jun 30, 2026
Last update
Jul 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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