Gynecological Laparoscopic SurgeryNCT07372209
Effects and Safety of Oliceridine in Anesthesia Induction:A Randomised Controlled Trial
A study testing Oliceridine and Sufentanil in people with Gynecological Laparoscopic Surgery and General Anesthetic, run by Tangshan Maternal and Child Health Hospital at 1 site in China.
Trial summary
to investigate whether oliceridine is safe and effective for induction of anesthesia by comparing henodynamic changes before and after endotracheal intubation with sufentanil Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Gynecological Laparoscopic Surgery, General Anesthetic, Intubation
- What is being tested?
- Oliceridine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years;
- American Society of Anesthesiologists (ASA) physical status I-II;
- Elective gynecologic laparoscopic surgery;
- Expected operative time 60-180 minutes;
Who cannot join
- Severe cardiovascular instability (e.g., acute decompensated heart failure, acute myocardial infarction, or life-threatening arrhythmia);
- Uncontrolled hypertension;
- Severe renal or hepatic dysfunction;
- Severe mental disorder or psychiatric illness;
- Known allergy or hypersensitivity to opioids;
- History of alcohol abuse or opioid addiction;
- Anticipated difficult airway;
- Pregnancy or lactation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Effects and Underlying Mechanisms of Analgesic Drugs on Inflammatory Pathways and Immune Function in Patients With Endometrial Cancer
to investigate whether oliceridine is safe and effective for induction of anesthesia by comparing henodynamic changes before and after endotracheal intubation with sufentanil
- Being tested
- Oliceridine, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Oliceridine is diluted to a 1mg/kg injection solution
SufentanilDrug
sufentanil is diluted to a 5μg/ml injection solution
| Study group | Role | What they receive |
|---|---|---|
| sufentanil | Active comparator | 0.5μg/kg of sufentanil was used for anesthesia induction Receives: Drug: Sufentanil |
| Oliceridine | Experimental | 0.13mg/kg oliceridine was used for anesthesia induction Receives: Drug: Oliceridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation
heart beat
Measured: baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation
Secondary outcomes (1)
adverse reactions
Measured: from the administration of sufentanil or oliceridine until discharge from the post-anesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Oct 2025
- Primary completion15 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gynecological Laparoscopic SurgeryStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tangshan Maternal and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zhang, Tangshan Maternal and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372209
- Sponsor's protocol ID
- 2024-074-01
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simons P, van der Schrier R, van Lemmen M, Jansen S, Kuijpers KWK, van Velzen M, Sarton E, Nicklas T, Michalsky C, Demitrack MA, Fossler M, Olofsen E, Niesters M, Dahan A. Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine. Anesthesiology. 2023 Mar 1;138(3):249-263. doi: 10.1097/ALN.0000000000004473.
PubMed 36538359Stahl EL, Schmid CL, Acevedo-Canabal A, Read C, Grim TW, Kennedy NM, Bannister TD, Bohn LM. G protein signaling-biased mu opioid receptor agonists that produce sustained G protein activation are noncompetitive agonists. Proc Natl Acad Sci U S A. 2021 Nov 30;118(48):e2102178118. doi: 10.1073/pnas.2102178118.
PubMed 34819362Yang W, Zhou R, Zhou X, Chen X, Zhou D, Zhang X. Effective Dose of Oliceridine Fumarate Co-Administered with Remimazolam in Suppressing Gastroscope Insertion Responses for Adults. Drug Des Devel Ther. 2025 Jun 10;19:5033-5041. doi: 10.2147/DDDT.S527586. eCollection 2025.
PubMed 40524805Ma B, Li Y, Leng C, Ji A, Zhang N, Tao X, Cao Q, Wang S. A Comparative Evaluation of the Safety and Efficacy of Oliceridine and Sufentanil in Gastrointestinal Endoscopy: A Single-Center, Randomized Controlled Trial. Drug Des Devel Ther. 2025 Jun 17;19:5111-5121. doi: 10.2147/DDDT.S512529. eCollection 2025.
PubMed 40546662Iannuzzi E, Iannuzzi M, Cirillo V, Viola G, Parisi R, Cerulli A, Chiefari M. Peri-intubation cardiovascular response during low dose remifentanil or sufentanil administration in association with propofol TCI. A double blind comparison. Minerva Anestesiol. 2004 Mar;70(3):109-15.
PubMed 14997083Teong CY, Huang CC, Sun FJ. The Haemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: A Randomised Controlled Trial. Sci Rep. 2020 Jun 1;10(1):8829. doi: 10.1038/s41598-020-65711-9.
PubMed 32483139
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects and Underlying Mechanisms of Analgesic Drugs on Inflammatory Pathways and Immune Function in Patients With Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07372209
- Acronym / sponsor ID
- 2024-074-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tangshan Maternal and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Jan 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.
to investigate whether oliceridine is safe and effective for induction of anesthesia by comparing henodynamic changes before and after endotracheal intubation with sufentanil
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 |
|---|---|---|
| sufentanil | Active comparator | Drug: Sufentanil0.5μg/kg of sufentanil was used for anesthesia induction |
| Oliceridine | Experimental | Drug: Oliceridine0.13mg/kg oliceridine was used for anesthesia induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years;
- American Society of Anesthesiologists (ASA) physical status I-II;
- Elective gynecologic laparoscopic surgery;
- Expected operative time 60-180 minutes;
Key exclusion criteria (8 listed)
- Severe cardiovascular instability (e.g., acute decompensated heart failure, acute myocardial infarction, or life-threatening arrhythmia);
- Uncontrolled hypertension;
- Severe renal or hepatic dysfunction;
- Severe mental disorder or psychiatric illness;
- Known allergy or hypersensitivity to opioids;
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 |
|---|---|---|
| OliceridineOliceridine is diluted to a 1mg/kg injection solution | Drug | Oliceridine |
| Sufentanilsufentanil is diluted to a 5μg/ml injection solution | Drug | sufentanil |
Primary outcome
blood pressure
Time frame: baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation
heart beat
Time frame: baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation
1 secondary outcome
adverse reactions
Time frame: from the administration of sufentanil or oliceridine until discharge from the post-anesthesia care unit (PACU)
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 28 Jan 2026.
- Background: PubMed 36538359Simons P, van der Schrier R, van Lemmen M, Jansen S, Kuijpers KWK, van Velzen M, Sarton E, Nicklas T, Michalsky C, Demitrack MA, Fossler M, Olofsen E, Niesters M, Dahan A. Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine. Anesthesiology. 2023 Mar 1;138(3):249-263. doi: 10.1097/ALN.0000000000004473.
- Background: PubMed 34819362Stahl EL, Schmid CL, Acevedo-Canabal A, Read C, Grim TW, Kennedy NM, Bannister TD, Bohn LM. G protein signaling-biased mu opioid receptor agonists that produce sustained G protein activation are noncompetitive agonists. Proc Natl Acad Sci U S A. 2021 Nov 30;118(48):e2102178118. doi: 10.1073/pnas.2102178118.
- Background: PubMed 40524805Yang W, Zhou R, Zhou X, Chen X, Zhou D, Zhang X. Effective Dose of Oliceridine Fumarate Co-Administered with Remimazolam in Suppressing Gastroscope Insertion Responses for Adults. Drug Des Devel Ther. 2025 Jun 10;19:5033-5041. doi: 10.2147/DDDT.S527586. eCollection 2025.
- Background: PubMed 40546662Ma B, Li Y, Leng C, Ji A, Zhang N, Tao X, Cao Q, Wang S. A Comparative Evaluation of the Safety and Efficacy of Oliceridine and Sufentanil in Gastrointestinal Endoscopy: A Single-Center, Randomized Controlled Trial. Drug Des Devel Ther. 2025 Jun 17;19:5111-5121. doi: 10.2147/DDDT.S512529. eCollection 2025.
- Background: PubMed 14997083Iannuzzi E, Iannuzzi M, Cirillo V, Viola G, Parisi R, Cerulli A, Chiefari M. Peri-intubation cardiovascular response during low dose remifentanil or sufentanil administration in association with propofol TCI. A double blind comparison. Minerva Anestesiol. 2004 Mar;70(3):109-15.
- Background: PubMed 32483139Teong CY, Huang CC, Sun FJ. The Haemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: A Randomised Controlled Trial. Sci Rep. 2020 Jun 1;10(1):8829. doi: 10.1038/s41598-020-65711-9.
- Individual participant dataSharing planned: No
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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 Oliceridine and Sufentanil in people with Gynecological Laparoscopic Surgery and General Anesthetic, 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 4 inclusion and 8 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 28 Jan 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?
blood pressure (time frame: baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation). The study lists 2 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 NCT07372209, which also lists 6 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 28 Jan 2026.