Gynecologic Surgical ProceduresPhase 4NCT07026162
Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery
A Phase 4 study testing Oliceridine and Sufentanil in people with Gynecologic Surgical Procedures and Postoperative Nausea and Vomiting (PONV), run by YanYing Xiao at 1 site in China.
Trial summary
The aim of this clinical trial is to evaluate the impact of the analgesic Oliceridine on postoperative nausea and vomiting (PONV) following gynecological laparoscopic surgery. It will also assess the safety profile of Oliceridine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gynecologic Surgical Procedures, Postoperative Nausea and Vomiting (PONV), Laparoscopy
- What is being tested?
- Oliceridine and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2025to 25 Feb 2026
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective gynecological laparoscopic surgery;
- Age 18-65 years;
- ASA physical status I-III;
- Body mass index (BMI) 18-30 kg/m².
Who cannot join
- Severe dysfunction of major organs such as the heart, lungs, or brain;
- History of allergy to opioid drugs, propofol, soybeans, or eggs;
- Recent use of sedatives, analgesics, or monoamine oxidase inhibitors;
- History of alcohol abuse;
- Obstructive sleep apnea syndrome;
- Difficult airway;
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- Psychiatric or neurological disorders; communication disorders;
- Women who are lactating or pregnant.
- Withdrawal criteria:
- Subject requests withdrawal or withdraws voluntarily;
- Change in surgical method requiring combined gastrointestinal surgery;
- Occurrence of allergy to the investigational drug or life-threatening complications;
- Reoperation within 48 hours postoperatively due to bleeding or other factors.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
Official title: Series Study on the Application of G Protein-Biased Receptor Agonist Oliceridine in Gynecological Surgery (2)：Effects of Oliceridine Versus Sufentanil on Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery
The aim of this clinical trial is to evaluate the impact of the analgesic Oliceridine on postoperative nausea and vomiting (PONV) following gynecological laparoscopic surgery. It will also assess the safety profile of Oliceridine. The trial seeks to address the following key questions:
Can Oliceridine reduce the incidence of postoperative nausea and vomiting (PONV) in gynecological laparoscopic surgery? Does the incidence of PONV differ between patients receiving Oliceridine and those receiving the commonly used analgesic sufentanil in gynecological laparoscopic surgery? Are there any opioid-related adverse reactions in gynecological laparoscopic surgery patients using Oliceridine?
Read more
Participants will:
Receive Oliceridine or sufentanil for anesthesia induction, maintenance, and postoperative pain management.
Vital signs during surgery and the occurrence of postoperative nausea and vomiting will be recorded.
Be followed up for at least 48 hours.
Read the detailed description
Study Design:
This randomized, double-blind, parallel-controlled trial compares oliceridine versus sufentanil for anesthesia/analgesia in gynecologic laparoscopy at Second Xiangya Hospital. The study features:
- Randomization: Computer-generated 1:1 allocation via sealed envelopes
- Blinding: Triple-blinding (participants, clinicians, outcome assessors) maintained through: Identical drug preparations (volume/appearance-matched);Separation between anesthesia nurses preparing drugs and clinical/research teams
- Control: Active comparator (sufentanil) reflecting current standard practice.
Technical Methodology：
- Anesthesia Protocol: Standardized induction with midazolam (0.05-0.10 mg/kg), study drug (sufentanil 0.3 μg/kg vs oliceridine 0.06 mg/kg), propofol (1.5-2.0 mg/kg), and cisatracurium (0.2-0.3 mg/kg). Maintenance via TIVA: propofol (4-10 mg/kg/h) + remifentanil (0.1-0.2 μg/kg/min). Pre-incision/closure boluses: Study drug dosed per group (sufentanil 0.1-0.2 μg/kg vs oliceridine 0.02-0.04 mg/kg).
- Analgesia Management: PCA pump configuration: Sufentanil group: 2 μg/kg in 100 mL NS; Oliceridine group: 0.4 mg/kg in 100 mL NS; Fixed adjuncts: ondansetron 8 mg + dexamethasone 10 mg.Demand dose: 2 mL (lockout 10 min), max 10 mL/h.
- Rescue Protocols: Analgesia: Sufentanil 5 μg or oliceridine 0.2 mg IV PRN; PONV: Ondansetron 4 mg + dexamethasone 5 mg; haloperidol 1 mg if refractory.
Quality Assurance Measures:
Anesthesia depth monitoring: BIS-guided propofol titration; Hemodynamic stability: Protocolized management of hypotension (defined as MAP <65 mmHg); Data validation: 10% random audit of time-stamped outcomes (PACU discharge, bowel recovery).
Pharmacokinetic Considerations:
Oliceridine dosing based on morphine equivalence (1mg ≈ 5mg morphine); Adjusted intraoperative dosing to account for context-sensitive half-time differences vs sufentanil.
Statistical Approach: Sample size:
Powered for PONV incidence difference (α=0.05, β=0.2); Analysis: ITT principle with sensitivity analysis for protocol deviations; Covariate adjustment: Stratification by Apfel risk factors (female sex, non-smoking, PONV history, opioid use).
- Being tested
- Oliceridine, Sufentanil
- Keywords
- Laparoscopy, Gynecologic Surgical Procedures, postoperative nausea and vomiting, Oliceridine
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Also called TRV130, olinvyk
For gynecological laparoscopic surgery, general anesthesia was induced with Oliceridine at a dose of 0.06 mg/kg (Yichang Renfu Pharmaceutical Co., Ltd., China). Intraoperative analgesia was administered with a total dose of Oliceridine ranging from 0.1 to 0.15 mg/kg. Postoperatively, Oliceridine was administered through a patient-controlled analgesia (PCA) system.
SufentanilDrug
For gynecological laparoscopic surgery, general anesthesia was induced with Sufentanil at a dose of 0.3 µg/kg (Yichang Renfu Pharmaceutical Co., Ltd., China). Intraoperative analgesia was provided with a total dose of Oliceridine ranging from 0.5 to 0.8 µg/kg. Postoperatively, Sufentanil was administered through a patient-controlled analgesia (PCA) system.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine group | Experimental | Anesthesia and analgesia with Oliceridine Receives: Drug: Oliceridine |
| Sufentanil group | Other | Anesthesia and analgesia with sufentanil Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting(PONV)
PONV will be assessed within 48 hours postoperatively in the ward by a blinded investigator. Subjects are required to use the simplified PONV impact scale to report whether any PONV events occurred in the past 48 hours and to provide a rating. (Q1. Have you experienced vomiting or symptoms of vomiting? If yes, how many episodes in total? Under what circumstances did it occur? Was any medication administered for treatment? Q2. Have you experienced nausea? If yes, did the sensation of nausea affect your daily activities? Was any medication administered for treatment?) Mild PONV is defined as mild nausea or a single vomiting episode caused by water or physical activity. Moderate PONV includes two vomiting episodes or significant nausea needing rescue therapy. Severe PONV is more than two vomiting episodes or requiring multiple doses of rescue therapy. Absence of symptoms requiring treatment is considered complete remission.
Measured: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
Secondary outcomes (9)
Incidence of postoperative vomiting (POV) postoperative 48 hours
Occurrence of postoperative vomiting postoperative 48 hours
Measured: From the time of awakening to 48 hours postoperatively. Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
Rescue antiemetic medications
Record rescue antiemetic medication use within 48 hours postoperatively
Measured: From awakening to 48 hours postoperatively
Postoperative Visual Analog Scale (VAS) score
Resting visual analog scale (VAS) pain scores within 48 hours postoperatively, measured using a 10 cm movable ruler with a numerical scale of 0-10 on the reverse side. The left end ("0") indicates no pain, while the right end ("10") represents unbearable severe pain.
Measured: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
Ramsay sedation score
Ramsay sedation score at 2 hours postoperatively: a score of 1 indicates agitation, 3 or 4 indicates somnolence, and 5 or 6 indicates excessive sedation
Measured: Postoperative 2 hours
Sleep quality score
Patient sleep quality will be assessed using a numerical rating scale based on an 11-point Likert scale, ranging from 0 to 10. A score of 0 indicates complete insomnia and extremely poor sleep quality, while a score of 10 represents excellent sleep quality. Severe insomnia is defined as a score of 0-3, moderate insomnia as 4-6, and good sleep quality as 7-10.
Measured: At the night of the surgery day, Day 0
Quality of Recovery-15 (QOR-15) score
A score of 0 indicates extremely poor quality of recovery, while a score of 150 indicates excellent quality of recovery. Assessments will be conducted preoperatively, on postoperative day 1, and on postoperative day 3.
Measured: Preoperative, postoperative day 1, and postoperative day 3, respectively
The time of the first postoperative bowel gas passage
The time from the end of surgery to the first postoperative passing of gas
Measured: From end of surgery until first postoperative passing of gas, assessed up to 72 hours.
Time staying in the PACU
The time from the patient's arrival to discharge from the PACU
Measured: From PACU arrival until discharge, assessed up to 6 hours.
Intraoperative hypotension
Hypotension is defined as a mean arterial pressure (MAP) less than 65 mmHg lasting for one minute, during the surgery from the anesthesia induction until the patient leaves the PACU.
Measured: From anesthesia induction until PACU discharge, assessed up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start21 Jul 2025
- Primary completion10 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Surgical ProceduresStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- YanYing Xiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YanYing Xiao, Second Xiangya Hospital of Central South University
- Investigators
- Xiao, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026162
- Sponsor's protocol ID
- LYEC2024-0425
- Status last verified
- Jul 2025
- First submitted
- 27 May 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Series Study on the Application of G Protein-Biased Receptor Agonist Oliceridine in Gynecological Surgery (2)：Effects of Oliceridine Versus Sufentanil on Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07026162
- Acronym / sponsor ID
- LYEC2024-0425
- Keywords
- Laparoscopy, Gynecologic Surgical Procedures, postoperative nausea and vomiting, Oliceridine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- YanYing XiaoUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 18 Jun 2025 (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.
The aim of this clinical trial is to evaluate the impact of the analgesic Oliceridine on postoperative nausea and vomiting (PONV) following gynecological laparoscopic surgery. It will also assess the safety profile of Oliceridine. The trial seeks to address the following key questions:
Can Oliceridine reduce the incidence of postoperative nausea and vomiting (PONV) in gynecological laparoscopic surgery? Does the incidence of PONV differ between patients receiving Oliceridine and those receiving the commonly used analgesic sufentanil in gynecological laparoscopic surgery? Are there any opioid-related adverse reactions in gynecological laparoscopic surgery patients using Oliceridine?
Participants will:
Receive Oliceridine or sufentanil for anesthesia induction, maintenance, and postoperative pain management.
Vital signs during surgery and the occurrence of postoperative nausea and vomiting will be recorded.
Be followed up for at least 48 hours.
Detailed description
Study Design:
This randomized, double-blind, parallel-controlled trial compares oliceridine versus sufentanil for anesthesia/analgesia in gynecologic laparoscopy at Second Xiangya Hospital. The study features:
- Randomization: Computer-generated 1:1 allocation via sealed envelopes
- Blinding: Triple-blinding (participants, clinicians, outcome assessors) maintained through: Identical drug preparations (volume/appearance-matched);Separation between anesthesia nurses preparing drugs and clinical/research teams
- Control: Active comparator (sufentanil) reflecting current standard practice.
Technical Methodology：
- Anesthesia Protocol: Standardized induction with midazolam (0.05-0.10 mg/kg), study drug (sufentanil 0.3 μg/kg vs oliceridine 0.06 mg/kg), propofol (1.5-2.0 mg/kg), and cisatracurium (0.2-0.3 mg/kg). Maintenance via TIVA: propofol (4-10 mg/kg/h) + remifentanil (0.1-0.2 μg/kg/min). Pre-incision/closure boluses: Study drug dosed per group (sufentanil 0.1-0.2 μg/kg vs oliceridine 0.02-0.04 mg/kg).
- Analgesia Management: PCA pump configuration: Sufentanil group: 2 μg/kg in 100 mL NS; Oliceridine group: 0.4 mg/kg in 100 mL NS; Fixed adjuncts: ondansetron 8 mg + dexamethasone 10 mg.Demand dose: 2 mL (lockout 10 min), max 10 mL/h.
- Rescue Protocols: Analgesia: Sufentanil 5 μg or oliceridine 0.2 mg IV PRN; PONV: Ondansetron 4 mg + dexamethasone 5 mg; haloperidol 1 mg if refractory.
Quality Assurance Measures:
Anesthesia depth monitoring: BIS-guided propofol titration; Hemodynamic stability: Protocolized management of hypotension (defined as MAP <65 mmHg); Data validation: 10% random audit of time-stamped outcomes (PACU discharge, bowel recovery).
Pharmacokinetic Considerations:
Oliceridine dosing based on morphine equivalence (1mg ≈ 5mg morphine); Adjusted intraoperative dosing to account for context-sensitive half-time differences vs sufentanil.
Statistical Approach: Sample size:
Powered for PONV incidence difference (α=0.05, β=0.2); Analysis: ITT principle with sensitivity analysis for protocol deviations; Covariate adjustment: Stratification by Apfel risk factors (female sex, non-smoking, PONV history, opioid use).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oliceridine group | Experimental | Drug: OliceridineAnesthesia and analgesia with Oliceridine |
| Sufentanil group | Other | Drug: SufentanilAnesthesia and analgesia with sufentanil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective gynecological laparoscopic surgery;
- Age 18-65 years;
- ASA physical status I-III;
- Body mass index (BMI) 18-30 kg/m².
Key exclusion criteria (13 listed)
- Severe dysfunction of major organs such as the heart, lungs, or brain;
- History of allergy to opioid drugs, propofol, soybeans, or eggs;
- Recent use of sedatives, analgesics, or monoamine oxidase inhibitors;
- History of alcohol abuse;
- Obstructive sleep apnea syndrome;
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 |
|---|---|---|
| OliceridineAlso: TRV130, olinvykFor gynecological laparoscopic surgery, general anesthesia was induced with Oliceridine at a dose of 0.06 mg/kg (Yichang Renfu Pharmaceutical Co., Ltd., China). Intraoperative analgesia was administered with a total dose of Oliceridine ranging from 0.1 to 0.15 mg/kg. Postoperatively, Oliceridine was administered through a patient-controlled analgesia (PCA) system. | Drug | Oliceridine group |
| SufentanilFor gynecological laparoscopic surgery, general anesthesia was induced with Sufentanil at a dose of 0.3 µg/kg (Yichang Renfu Pharmaceutical Co., Ltd., China). Intraoperative analgesia was provided with a total dose of Oliceridine ranging from 0.5 to 0.8 µg/kg. Postoperatively, Sufentanil was administered through a patient-controlled analgesia (PCA) system. | Drug | Sufentanil group |
Primary outcome
Incidence of postoperative nausea and vomiting(PONV)
Time frame: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
PONV will be assessed within 48 hours postoperatively in the ward by a blinded investigator. Subjects are required to use the simplified PONV impact scale to report whether any PONV events occurred in the past 48 hours and to provide a rating. (Q1. Have you experienced vomiting or symptoms of vomiting? If yes, how many episodes in total? Under what circumstances did it occur? Was any medication administered for treatment? Q2. Have you experienced nausea? If yes, did the sensation of nausea affect your daily activities? Was any medication administered for treatment?) Mild PONV is defined as mild nausea or a single vomiting episode caused by water or physical activity. Moderate PONV includes two vomiting episodes or significant nausea needing rescue therapy. Severe PONV is more than two vomiting episodes or requiring multiple doses of rescue therapy. Absence of symptoms requiring treatment is considered complete remission.
9 secondary outcomes
Incidence of postoperative vomiting (POV) postoperative 48 hours
Time frame: From the time of awakening to 48 hours postoperatively. Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
Rescue antiemetic medications
Time frame: From awakening to 48 hours postoperatively
Postoperative Visual Analog Scale (VAS) score
Time frame: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
Ramsay sedation score
Time frame: Postoperative 2 hours
Sleep quality score
Time frame: At the night of the surgery day, Day 0
Quality of Recovery-15 (QOR-15) score
Time frame: Preoperative, postoperative day 1, and postoperative day 3, respectively
The time of the first postoperative bowel gas passage
Time frame: From end of surgery until first postoperative passing of gas, assessed up to 72 hours.
Time staying in the PACU
Time frame: From PACU arrival until discharge, assessed up to 6 hours.
Intraoperative hypotension
Time frame: From anesthesia induction until PACU discharge, assessed up to 6 hours.
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
Xiao principal investigator
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oliceridine and Sufentanil in people with Gynecologic Surgical Procedures and Postoperative Nausea and Vomiting (PONV), run by YanYing Xiao 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 13 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 9 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of postoperative nausea and vomiting(PONV) (time frame: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.