Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing

About this trial

This single-center, double-blind, randomized controlled trial aims to determine whether oliceridine for patient-controlled intravenous analgesia (PCIA) can significantly reduce the incidence of postoperative nausea, an opioid-related adverse reaction, compared to sufentanil PCIA in patients undergoing cerebellopontine angle (CPA) region surgery. A secondary objective is to compare the postoperative analgesic effects between the two drugs. The study plans to enroll 174 patients (with a calculated sample size of 164 plus 5% for attrition). The primary outcome is the incidence of nausea within 6-48 hours postoperatively. Secondary outcomes include pain scores at rest and during movement within 48 hours, and other exploratory outcomes such as vomiting incidence, time to first flatus/defecation, and gastrointestinal function scores.

Eligibility criteria

Qualifiers

Scheduled for elective CPA region surgery with planned PCIA.

Age 18-65 years.

ASA physical status I-III.

Provides written informed consent.

Disqualifiers

Opioid tolerance (taking opioids ≥1 week, equivalent to oral morphine ≥50 mg/day or oxycodone ≥30 mg/day).

Severe cardiopulmonary, hepatic, renal, vascular, neurological, hematological, gastrointestinal, or endocrine diseases.

Postoperative ICU admission with tracheal intubation.

BMI ≤18.5 or ≥30 kg/m².

Trial design

Treatments tested in this trial

  • Oliceridine
  • Sufentanil

Treatment groups

174 Participants
are divided into 2 treatment groups

Sponsors and collaborators