Gastrointestinal DysfunctionNCT07650812

Oliceridine for Gastrointestinal Dysfunction

A study testing Experimental: Oliceridine group and Active Comparator: Classical opioid group in people with Gastrointestinal Dysfunction, run by Beijing Tiantan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Dysfunction
What is being tested?: Experimental: Oliceridine group and Active Comparator: Classical opioid group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 176 participants
Where: No sites listed yet
Study dates: 1 Jul 2026to 30 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing selective neurosurgical resection of craniocerebral tumors;
Age ≥ 18 years old;
American Society of Anesthesiologists (ASA) grade 1-3;
Sign the informed consent form.

Who cannot join

Patients unable to complete scale assessment due to preoperative language dysfunction or communication impairment;
Patients with preoperative symptoms of posterior cranial nerve injury and who need to retain a tracheal tube;
Patients with insular, brainstem, or medullary lesions that may impair early postoperative recovery of consciousness;
Patients undergoing intracranial lesion resection via the transsphenoidal approach;
Patients with a history of previous abdominal surgery;
Patients with BMI > 35.0 kg/m2;

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Patients with liver or kidney dysfunction;
Patients with a history of allergic or adverse reactions to the test drug;
Patients with a history of drug abuse;
Pregnant or lactating women.

About this study

Official title: The Effect of Oliceridine on Gastrointestinal Dysfunction and Pain Management in Patients Undergoing Neurosurgery: a Randomized Controlled Trial

Gastrointestinal dysfunction is common in patients after major surgery, especially for neurosurgery. It was reported 80% of neurosurgery patients could be combined with gastrointestinal dysfunction, and it may relate to old age, surgery time, and factors of anesthesia and surgery. Meanwhile, postoperative constipation, nausea, and vomiting induced by gastrointestinal dysfunction may increase the intracranial bleeding. Oliceridine could activate mu opioid receptors without the interaction of (beta)arr2-muOR, and may reduce the gastrointestinal dysfunction, but a limited study has illustrated this topic. Thus, this study is conducted to explore whether oliceridine could reduce the gastrointestinal dysfunction vs. sufentanil in patients undergoing neurosurgery.

Conditions: Gastrointestinal Dysfunction
Being tested: Experimental: Oliceridine group, Active Comparator: Classical opioid group

What participants receive

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

Experimental: Oliceridine groupDrug
During the operation, both the induction and maintenance of anesthesia as well as the analgesic drugs were administered with oxilazide. The dosage and administration timing of the drugs were determined by the anesthesiologist.
Active Comparator: Classical opioid groupDrug
During the operation, both the induction and maintenance of anesthesia were achieved using sufentanil. The dosage and administration timing of the drugs were determined by the anesthesiologist.

Study groups in NCT07650812
Study group	Role	What they receive
Oliceridine group	Experimental	Not described Receives: Drug: Experimental: Oliceridine group
Classical opioid group	Active comparator	Not described Receives: Drug: Active Comparator: Classical opioid group

What is being measured

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

High risk rate of gastrointestinal dysfunction
The high-risk rate of postoperative gastrointestinal dysfunction was assessed using the Intake, feeling nauseated, emesis, physical examination, and duration of symptoms (I-FEED) scoring system.
Measured: Within 72 hours after the operation

Timeline

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

1 Jul 202630 Dec 2027

First posted16 Jun 2026
Study start1 Jul 2026 (estimated)
Primary completion15 Dec 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
More trials run by Beijing Tiantan 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 176 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07650812
Sponsor's protocol ID: WJPOliceridine
Status last verified: Jun 2026
First submitted: 31 May 2026
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Oliceridine on Gastrointestinal Dysfunction and Pain Management in Patients Undergoing Neurosurgery: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07650812
Acronym / sponsor ID: WJPOliceridine
Conditions: Gastrointestinal Dysfunction
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 176 participants (estimated)
Lead sponsor: Beijing Tiantan HospitalUniversity, hospital or other
Study start: 1 Jul 2026 (estimated)
Primary completion: 15 Dec 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 16 Jun 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.

Study design

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

Arm	Type	Receives
Oliceridine group	Experimental	Drug: Experimental: Oliceridine group
Classical opioid group	Active comparator	Drug: Active Comparator: Classical opioid group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients undergoing selective neurosurgical resection of craniocerebral tumors;
Age ≥ 18 years old;
American Society of Anesthesiologists (ASA) grade 1-3;
Sign the informed consent form.

Key exclusion criteria (10 listed)

Patients unable to complete scale assessment due to preoperative language dysfunction or communication impairment;
Patients with preoperative symptoms of posterior cranial nerve injury and who need to retain a tracheal tube;
Patients with insular, brainstem, or medullary lesions that may impair early postoperative recovery of consciousness;
Patients undergoing intracranial lesion resection via the transsphenoidal approach;
Patients with a history of previous abdominal surgery;

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
Experimental: Oliceridine groupDuring the operation, both the induction and maintenance of anesthesia as well as the analgesic drugs were administered with oxilazide. The dosage and administration timing of the drugs were determined by the anesthesiologist.	Drug	Oliceridine group
Active Comparator: Classical opioid groupDuring the operation, both the induction and maintenance of anesthesia were achieved using sufentanil. The dosage and administration timing of the drugs were determined by the anesthesiologist.	Drug	Classical opioid group

Primary outcome

High risk rate of gastrointestinal dysfunction
Time frame: Within 72 hours after the operation
The high-risk rate of postoperative gastrointestinal dysfunction was assessed using the Intake, feeling nauseated, emesis, physical examination, and duration of symptoms (I-FEED) scoring system.

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 16 Jun 2026.

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Oliceridine group and Active Comparator: Classical opioid group in people with Gastrointestinal Dysfunction, run by Beijing Tiantan Hospital.

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 10 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: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

High risk rate of gastrointestinal dysfunction (time frame: Within 72 hours after the operation). 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 NCT07650812.

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 16 Jun 2026.