Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery

Comparative Study of Oliceridine Versus Sufentanil for Patient-Controlled Intravenous Analgesia in Improving Postoperative Nausea in Patients Undergoing Cerebellopontine Angle Region Surgery.

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.

Study Overview

• Status: Recruiting
• Conditions: PONV; Postoperative Analgesia; Cerebellopontine Angle Tumor; Microvascular Decompression Surgery
• Intervention / Treatment: Drug: Oliceridine; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Xiao, Dr.; Phone Number: +86-13810971299; Email: kitten15@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Xiao, Dr.; Phone Number: +86-13810971299; Email: kitten15@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Scheduled for elective CPA region surgery with planned PCIA.
• Age 18-65 years.
• ASA physical status I-III.
• Provides written informed consent.

Exclusion Criteria:

• 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.
• Participation in another clinical trial within 3 months prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oliceridine; Loading dose of 1.5 mg IV at dural closure. PCIA pump: Oliceridine 0.4 mg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min, maximum 27 mg/24h. Duration: 48h.	Drug: Oliceridine; Loading dose of 1.5 mg IV at dural closure. PCIA pump: Oliceridine 0.4 mg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min, maximum 27 mg/24h. Duration: 48h.
Active Comparator: Sufentanil; Loading dose of 7.5 mcg IV at dural closure. PCIA pump: Sufentanil 2 mcg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min. Duration: 48h.	Drug: Sufentanil; Loading dose of 7.5 mcg IV at dural closure. PCIA pump: Sufentanil 2 mcg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min. Duration: 48h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Nausea	Defined as the subjective feeling of wanting to vomit, lasting ≥5 minutes.	6 to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity	Assessed using the Verbal Rating Scale (VRS, 0-10) at rest and during movement.	Within 48 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Vomiting (Clinician-Assessed Event Recording)	Occurrence of any vomiting episodes (defined as expulsion of gastric contents through the mouth or nose) within 48 hours after surgery, assessed via continuous clinical observation and bedside nursing documentation.	Within 48 hours after surgery.
Severity of Nausea and Vomiting	Assessed using a Visual Analogue Scale (VAS, 0-10, where 0=no nausea and 10=worst nausea imaginable).	Within 48 hours after surgery.
Use of Rescue Antiemetic Medication	Frequency and/or dose of administered rescue antiemetics (e.g., 5HT-3 receptor antagonists, metoclopramide).	Within 48 hours after surgery.
Time to First Flatus	Time from end of surgery to first passage of flatus, as self-reported by the patient or directly observed and documented by nursing or study staff.	From end of surgery up to 7 days postoperatively, with assessment for first passage of flatus conducted until documented or day 7, whichever comes first.
Time to First Defecation	Time from end of surgery to first bowel movement, as self-reported by the patient or directly observed and documented by nursing or study staff.	From end of surgery up to 7 days postoperatively, with assessment for first bowel movement conducted until documented or day 7, whichever comes first.
Incidence of Constipation	Presence of constipation, defined as meeting Rome IV criteria for functional constipation in postoperative period, assessed by clinical staff or patient self-report.	Up to 7 days postoperatively.
Gastrointestinal Symptom Score	Assessment of gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS). The scale consists of 15 items rated on a 7-point Likert scale (1 = no discomfort, 7 = severe discomfort). The total score ranges from 15 to 105, with higher scores indicating worse gastrointestinal symptom severity.	Baseline (within 24 hours before surgery) and up to postoperative day 7, with assessment at hospital discharge if discharge occurs earlier.
Postoperative Gastrointestinal Intolerance Score	Assessment of postoperative gastrointestinal intolerance using the Intake, Feeling nauseated, Emesis, Exam, and Duration (I-FEED) scoring system. The scale includes 5 domains (intake, nausea, emesis, physical exam findings, symptom duration) with a total score range of 0-14 points. Higher scores indicate worse gastrointestinal function: 0-2 = normal, 3-5 = postoperative gastrointestinal intolerance (POGI), ≥6 = postoperative gastrointestinal dysfunction (POGD).	Day 1 and Day 2 post-surgery.
Plasma Gastrointestinal Hormone Levels	Changes in levels of Pepsinogen I, Pepsinogen II, Gastrin-17, and Serotonin (5-HT).	Preoperative and on postoperative days 1-2.
Total Analgesic Drug Consumption	Total amount of study drug used via PCIA pump, converted to morphine milligram equivalents (MME).	Within 48 hours after surgery.
PCIA Pump Usage	Number of effective demands and total number of demands.	Within 48 hours after surgery.
Use of Rescue Analgesic Medication	Frequency and/or dose of administered rescue analgesics (e.g., NSAIDs).	Within 48 hours after surgery.
Subjective Sleep Quality	Assessment of subjective sleep quality using the Richards-Campbell Sleep Questionnaire (RCSQ). The scale consists of 5 items (sleep depth, sleep latency, awakenings, sleep quality, return to sleep after awakening) rated on a 100-mm visual analog scale, with a total score range of 0-100 points. Higher scores indicate better subjective sleep quality (scores ≥70 are generally considered indicative of good sleep quality).	Baseline (within 24 hours before surgery) and on postoperative days 1-2.
Incidence of Respiratory Depression	Defined as respiratory rate < 10 breaths/min or SpO₂ < 90% for >1 min, or PaCO₂ > 50 mmHg.	Within 48 hours after surgery.
Level of Sedation	Assessment of level of sedation and agitation using the Richmond Agitation-Sedation Scale (RASS). The scale ranges from -5 (unarousable) to +4 (combative/agitated), with a score of 0 (alert and calm) representing the optimal clinical state. Positive scores indicate increasing agitation, while negative scores indicate increasing sedation	Within 48 hours after surgery.
Incidence of Urinary Retention	Incidence of urinary retention, defined as patient-reported difficulty voiding or a post-void residual urine volume ≥150 mL (measured via bladder scan) within 48 hours after urinary catheter removal. This will be assessed by counting the number of participants meeting the above criteria.	Post-catheter removal within 48 hours.
Post-catheter removal within 48 hours.	Assessed using a Visual Analogue Scale (VAS, 0-10).	Within 48 hours after surgery.
Severity of Dizziness	Assessment of dizziness severity using the Dizziness Handicap Inventory (DHI) scale. The scale consists of 25 items rated on a 3-point scale (0 = no handicap, 2 = occasional handicap, 4 = severe handicap), with a total score range of 0-100 points. Higher scores indicate greater dizziness-related functional handicap (scores 0-30 = mild, 31-60 = moderate, 61-100 = severe handicap).	30 minutes, 6 hours, 12 hours, 1 day and 2 days after surgery.
Postoperative Hospital Length of Stay	Total number of days from the end of surgery to hospital discharge.	From end of surgery until hospital discharge, with assessment conducted up to 30 days postoperatively.
Need for ICU Treatment	Binary assessment (yes/no) of whether the patient required admission to the intensive care unit (ICU) during the postoperative period.	rom the end of surgery until the date of hospital discharge or death, whichever comes first, assessed up to 30 days postoperatively.
ICU Length of Stay	Total number of days spent in the ICU, if ICU admission occurred.	From ICU admission until ICU discharge (within the hospitalization period), with assessment conducted up to 30 days postoperatively.
Total Hospitalization Cost	Total direct medical costs incurred during the entire hospital stay (including surgery, ward care, ICU, medications, and laboratory tests).	From hospital admission until hospital discharge, with cost assessment conducted over the entire inpatient stay up to 30 days.

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Signs and Symptoms, Digestive; Neoplasms by Histologic Type; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Neuroendocrine Tumors; Ear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Neuroma; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Neuroma, Acoustic; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl; Sufentanil; ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine
• Other Study ID Numbers: Linyanshen[2025]419-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No