Oliceridine for Gastrointestinal Dysfunction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Dysfunction
• Intervention / Treatment: Drug: Experimental: Oliceridine group; Drug: Active Comparator: Classical opioid group

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oliceridine group	Drug: Experimental: Oliceridine group; 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 group	Drug: Active Comparator: Classical opioid group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 72 hours after the operation

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: WJPOliceridine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No