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NCT Number: NCT07650812

Oliceridine for Gastrointestinal Dysfunction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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