Oliceridine for Gastrointestinal Dysfunction

ConditionGastrointestinal Dysfunction

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeijing Tiantan Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

176 Participants

are divided into 2 treatment groups

Group A: Oliceridine groupExperimental treatment 1 intervention

Group B: Classical opioid groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Within 72 hours after the operation

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: