HysteroscopyNCT07713134

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

A study testing Sufentanil and Oliceridine in people with Hysteroscopy and Analgeisa, run by Tangshan Maternal and Child Health Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Hysteroscopy, Analgeisa
What is being tested?: Sufentanil and Oliceridine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 1 siteChina
Study dates: 1 Aug 2025to 30 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Tangshan Maternal and Child Health Hospital, Tangshan, Hebei 063000
Tangshan, Hebei

Other trials in China

About this study

Official title: Efficacy and Safety of the Biased μ-Opioid Receptor Agonist Oliceridine in Hysteroscopic Procedures

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

Conditions: Hysteroscopy, Analgeisa
Being tested: Sufentanil, Oliceridine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SufentanilDrug
sufentanil is diluted to a 5μg/ml injection solution
OliceridineDrug
Oliceridine is diluted to a 1mg/kg injection solution

Study groups in NCT07713134
Study group	Role	What they receive
sunfentanil	Active comparator	0.15μg/kg sufentanil was used as the analgic for patients undergoing office hysteroscopy Receives: Drug: Sufentanil
oliceridine	Experimental	0.04mg/kg sufentanil was used as the analgic for patients undergoing office hysteroscopy Receives: Drug: Oliceridine

What is being measured

The primary outcome is the main question the study is designed to answer.

heart rate（beats per minute）
Measured: before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery
mean arterial pressure(mmHg)
Measured: 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
Measured: at the end of the hysteroscopy procedure

Secondary outcomes (2)

number of participants with postoperative nausea and vomiting within 24 hours after surgery
Measured: within 24 hours after surgery
number of Participants with Intraoperative Respiratory Depression
Measured: from induction of anesthesia to completion of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202530 Jun 2026

First posted20 Jul 2026
Study start1 Aug 2025
Primary completion20 May 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HysteroscopyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07713134
Sponsor's protocol ID: 2026-013-01
Status last verified: Jun 2026
First submitted: 14 Jul 2026
Last updated: 20 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
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Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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All Hysteroscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of the Biased μ-Opioid Receptor Agonist Oliceridine in Hysteroscopic Procedures
ClinicalTrials.gov ID: NCT07713134
Acronym / sponsor ID: 2026-013-01
Conditions: Hysteroscopy, Analgeisa
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Tangshan Maternal and Child Health HospitalUniversity, hospital or other
Study start: 1 Aug 2025 (actual)
Primary completion: 20 May 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 20 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
sunfentanil	Active comparator	Drug: Sufentanil0.15μg/kg sufentanil was used as the analgic for patients undergoing office hysteroscopy
oliceridine	Experimental	Drug: Oliceridine0.04mg/kg sufentanil was used as the analgic for patients undergoing office hysteroscopy

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sufentanilsufentanil is diluted to a 5μg/ml injection solution	Drug	sunfentanil
OliceridineOliceridine is diluted to a 1mg/kg injection solution	Drug	oliceridine

Primary outcome

heart rate（beats per minute）
Time frame: before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery
mean arterial pressure(mmHg)
Time frame: 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
Time frame: at the end of the hysteroscopy procedure

2 secondary outcomes

number of participants with postoperative nausea and vomiting within 24 hours after surgery
Time frame: within 24 hours after surgery
number of Participants with Intraoperative Respiratory Depression
Time frame: from induction of anesthesia to completion of surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
Background: PubMed 41147005Chen 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.
Background: PubMed 33889018Tan 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.
Background: PubMed 40599606Yi 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.
Background: PubMed 39493926Lei 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.
Background: PubMed 41597456Anggraeni 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.
Individual participant dataSharing planned: No

Related trials for Hysteroscopy

Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sufentanil and Oliceridine in people with Hysteroscopy and Analgeisa, run by Tangshan Maternal and Child Health Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

heart rate（beats per minute） (time frame: before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07713134, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.