Oliceridine FumarateNCT07307495
Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery
A study testing Sufentanil and Oiceridine in people with Oliceridine Fumarate, run by Xijing Hospital at 1 site in China.
Trial summary
Osemitidine fumarate is a novel G protein-biased ligand μ-opioid receptor agonist. Previous studies have confirmed its potent analgesic effects and safety: compared with morphine, it reduces respiratory depression and gastrointestinal dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oliceridine Fumarate
- What is being tested?
- Sufentanil and Oiceridine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old;
- Patients undergoing lumbar surgery under general anesthesia (within 3 segments) and expected to receive postoperative patient-controlled analgesia;
- ASA classification I-III;
- BMI between 18 and 30 kg/m²;
- Informed consent obtained from the patient.
Who cannot join
- Use of any painkillers within 3 days before surgery; or long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), defined as: within 3 months before surgery, use of NSAIDs daily for more than 2 consecutive weeks;
- Presence of intestinal obstruction or suspicious symptoms: nausea and vomiting, abdominal bloating and pain, cessation of gas or bowel movements within the past two weeks, imaging suggesting intestinal dilation, or large amounts of air-fluid levels;
- Patients with severe liver dysfunction (based on Child-Pugh classification, grade C);
- History of or planned gastrointestinal surgery;
- Patients allergic to the study drug;
- Pregnant or breastfeeding patients;
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- QTcF abnormalities, males >450 ms, females >470 ms;
- Participation in other drug trials within the past 30 days;
- Long-term use of opioids (defined as: within 12 months before surgery, use for more than 1 month, more than 3 days per week, with daily doses exceeding 15 mg morphine equivalent);
- Pre-existing neurological or psychiatric disorders: such as epilepsy, depression, schizophrenia, etc.;
- Patients deemed unsuitable for this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710043
Hailong Dong, 029-84775337, hldong369@hotmail.com
About this study
Official title: Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery:A Prospective, Multicenter, Double-blind,Randomized Controlled Study
Osemitidine fumarate is a novel G protein-biased ligand μ-opioid receptor agonist. Previous studies have confirmed its potent analgesic effects and safety: compared with morphine, it reduces respiratory depression and gastrointestinal dysfunction. This study aims to evaluate the effects of osemitidine on postoperative gastrointestinal function recovery and pain in patients undergoing lumbar spine surgery through a multicenter, double-blind, randomized controlled trial.
- Conditions
- Oliceridine Fumarate
- Being tested
- Sufentanil, Oiceridine
- Keywords
- lumbar spine surgery, gastrointestinal function recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
The postoperative PCA analgesia pump configuration plan is 1.5 μg/kg sufentanil diluted with saline to 100 ml.
The specific parameters are a loading dose: 0.1 μg/kg sufentanil diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery.
Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout time: 10 minutes.
OiceridineDrug
The postoperative PCA analgesic pump regimen is 0.5 mg/kg of oliceridine diluted with saline to 100 ml. The specific parameters are a loading dose: 0.03 mg/kg of Oxycodone diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout interval: 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine Group | Experimental | Oliceridine Patient-Controlled Analgesia Pump After Lumbar Spine Surgery Receives: Drug: Oiceridine |
| Sufentanil Group | Active comparator | Sufentanil Patient-Controlled Analgesia Pump After Lumbar Spine Surgery Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours
Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 24 hours
Measured: postoperative 24 hours
Secondary outcomes (6)
Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours
Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 48 hours
Measured: postoperative 48 hours
GI-3
GI-3: Reach the later of the following two milestones:
① Time of solid food tolerance: No vomiting occurs within 4 hours after eating food that requires chewing ;
② Time of first flatus or first bowel movement (whichever comes first).
Measured: postoperative 48 hours
IFEED score
IFEED scores at postoperative 24 and 48 hours The I-FEED score is a novel outcome measure for POI, developed by expert consensus. It contains five elements (intake, response to nausea treatment, emesis, exam, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)(normal 0-2, POGI 3-5, POGD 6+ points)
Measured: postoperative 24 and 48 hours
Postoperative SPID
Summed Pain Intensity Difference at postoperative 24 and 48 hours
Measured: postoperative 24 and 48 hours
Opioid consumption
Opioid consumption at postoperative 24 and 48 hours
Measured: postoperative 24 and 48 hours
remedial analgesia
Times of remedial analgesia at postoperative 48 hours
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Mar 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oliceridine FumarateStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307495
- Sponsor's protocol ID
- KY20252506-F-2
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery:A Prospective, Multicenter, Double-blind,Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07307495
- Acronym / sponsor ID
- KY20252506-F-2
- Conditions
- Oliceridine Fumarate
- Keywords
- lumbar spine surgery, gastrointestinal function recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 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.
Osemitidine fumarate is a novel G protein-biased ligand μ-opioid receptor agonist. Previous studies have confirmed its potent analgesic effects and safety: compared with morphine, it reduces respiratory depression and gastrointestinal dysfunction. This study aims to evaluate the effects of osemitidine on postoperative gastrointestinal function recovery and pain in patients undergoing lumbar spine surgery through a multicenter, double-blind, randomized controlled trial.
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 |
|---|---|---|
| Oliceridine Group | Experimental | Drug: OiceridineOliceridine Patient-Controlled Analgesia Pump After Lumbar Spine Surgery |
| Sufentanil Group | Active comparator | Drug: SufentanilSufentanil Patient-Controlled Analgesia Pump After Lumbar Spine Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years old;
- Patients undergoing lumbar surgery under general anesthesia (within 3 segments) and expected to receive postoperative patient-controlled analgesia;
- ASA classification I-III;
- BMI between 18 and 30 kg/m²;
- Informed consent obtained from the patient.
Key exclusion criteria (11 listed)
- Use of any painkillers within 3 days before surgery; or long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), defined as: within 3 months before surgery, use of NSAIDs daily for more than 2 consecutive weeks;
- Presence of intestinal obstruction or suspicious symptoms: nausea and vomiting, abdominal bloating and pain, cessation of gas or bowel movements within the past two weeks, imaging suggesting intestinal dilation, or large amounts of air-fluid levels;
- Patients with severe liver dysfunction (based on Child-Pugh classification, grade C);
- History of or planned gastrointestinal surgery;
- Patients allergic to the study drug;
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 |
|---|---|---|
| SufentanilThe postoperative PCA analgesia pump configuration plan is 1.5 μg/kg sufentanil diluted with saline to 100 ml. The specific parameters are a loading dose: 0.1 μg/kg sufentanil diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout time: 10 minutes. | Drug | Sufentanil Group |
| OiceridineThe postoperative PCA analgesic pump regimen is 0.5 mg/kg of oliceridine diluted with saline to 100 ml. The specific parameters are a loading dose: 0.03 mg/kg of Oxycodone diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout interval: 10 minutes. | Drug | Oliceridine Group |
Primary outcome
Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours
Time frame: postoperative 24 hours
Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 24 hours
6 secondary outcomes
Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours
Time frame: postoperative 48 hours
GI-3
Time frame: postoperative 48 hours
IFEED score
Time frame: postoperative 24 and 48 hours
Postoperative SPID
Time frame: postoperative 24 and 48 hours
Opioid consumption
Time frame: postoperative 24 and 48 hours
remedial analgesia
Time frame: postoperative 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery
Acute Pain, Opioid Analgesic Adverse Reaction
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.
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 Oiceridine in people with Oliceridine Fumarate, run by Xijing 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 11 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: looking for participants now, as of the sponsor's last update on 5 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailong Dong (13669226699, hldong369@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours (time frame: postoperative 24 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 5 Aug 2026.