Oliceridine for Gastrointestinal Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Oliceridine group, Active Comparator: Classical opioid group.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Dysfunction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Oliceridine on Gastrointestinal Dysfunction and Pain Management in Patients Undergoing Neurosurgery: a Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- High risk rate of gastrointestinal dysfunction [Time frame: Within 72 hours after the operation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07650812 · WJPOliceridine