Oliceridine for Gastrointestinal Dysfunction

NCT07650812 | Not Yet Recruiting

• 1 other identifier: WJPOliceridine
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oliceridine group

EXPERIMENTAL

Drug: Experimental: Oliceridine group

Classical opioid group

ACTIVE COMPARATOR

Drug: Active Comparator: Classical opioid group

Interventions

Experimental: Oliceridine group DRUG

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.

Oliceridine group

Active Comparator: Classical opioid group DRUG

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.

Classical opioid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06