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NCT Number: NCT07479446

Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle 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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Oliceridine

Drug

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.

Sufentanil

Drug

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.

Primary outcomes

  1. Incidence of Postoperative Nausea

    Time frame: 6 to 48 hours after surgery

    Defined as the subjective feeling of wanting to vomit, lasting ≥5 minutes.

Secondary outcomes

  1. Postoperative Pain Intensity

    Time frame: Within 48 hours after surgery

    Assessed using the Verbal Rating Scale (VRS, 0-10) at rest and during movement.

Other outcomes

  1. Incidence of Postoperative Vomiting (Clinician-Assessed Event Recording)

    Time frame: Within 48 hours after surgery.

    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.

  2. Severity of Nausea and Vomiting

    Time frame: Within 48 hours after surgery.

    Assessed using a Visual Analogue Scale (VAS, 0-10, where 0=no nausea and 10=worst nausea imaginable).

  3. Use of Rescue Antiemetic Medication

    Time frame: Within 48 hours after surgery.

    Frequency and/or dose of administered rescue antiemetics (e.g., 5HT-3 receptor antagonists, metoclopramide).

  4. Time to First Flatus

    Time frame: 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 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.

  5. Time to First Defecation

    Time frame: From end of surgery up to 7 days postoperatively, with assessment for first bowel movement conducted until documented or day 7, whichever comes first.

    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.

  6. Incidence of Constipation

    Time frame: Up to 7 days postoperatively.

    Presence of constipation, defined as meeting Rome IV criteria for functional constipation in postoperative period, assessed by clinical staff or patient self-report.

  7. Gastrointestinal Symptom Score

    Time frame: Baseline (within 24 hours before surgery) and up to postoperative day 7, with assessment at hospital discharge if discharge occurs earlier.

    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.

  8. Postoperative Gastrointestinal Intolerance Score

    Time frame: Day 1 and Day 2 post-surgery.

    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).

  9. Plasma Gastrointestinal Hormone Levels

    Time frame: Preoperative and on postoperative days 1-2.

    Changes in levels of Pepsinogen I, Pepsinogen II, Gastrin-17, and Serotonin (5-HT).

  10. Total Analgesic Drug Consumption

    Time frame: Within 48 hours after surgery.

    Total amount of study drug used via PCIA pump, converted to morphine milligram equivalents (MME).

  11. PCIA Pump Usage

    Time frame: Within 48 hours after surgery.

    Number of effective demands and total number of demands.

  12. Use of Rescue Analgesic Medication

    Time frame: Within 48 hours after surgery.

    Frequency and/or dose of administered rescue analgesics (e.g., NSAIDs).

  13. Subjective Sleep Quality

    Time frame: Baseline (within 24 hours before surgery) and on postoperative days 1-2.

    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).

  14. Incidence of Respiratory Depression

    Time frame: Within 48 hours after surgery.

    Defined as respiratory rate < 10 breaths/min or SpO₂ < 90% for >1 min, or PaCO₂ > 50 mmHg.

  15. Level of Sedation

    Time frame: Within 48 hours after surgery.

    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

  16. Incidence of Urinary Retention

    Time frame: Post-catheter removal within 48 hours.

    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.

  17. Post-catheter removal within 48 hours.

    Time frame: Within 48 hours after surgery.

    Assessed using a Visual Analogue Scale (VAS, 0-10).

  18. Severity of Dizziness

    Time frame: 30 minutes, 6 hours, 12 hours, 1 day and 2 days after surgery.

    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).

  19. Postoperative Hospital Length of Stay

    Time frame: From end of surgery until hospital discharge, with assessment conducted up to 30 days postoperatively.

    Total number of days from the end of surgery to hospital discharge.

  20. Need for ICU Treatment

    Time frame: rom the end of surgery until the date of hospital discharge or death, whichever comes first, assessed up to 30 days postoperatively.

    Binary assessment (yes/no) of whether the patient required admission to the intensive care unit (ICU) during the postoperative period.

  21. ICU Length of Stay

    Time frame: From ICU admission until ICU discharge (within the hospitalization period), with assessment conducted up to 30 days postoperatively.

    Total number of days spent in the ICU, if ICU admission occurred.

  22. Total Hospitalization Cost

    Time frame: From hospital admission until hospital discharge, with cost assessment conducted over the entire inpatient stay up to 30 days.

    Total direct medical costs incurred during the entire hospital stay (including surgery, ward care, ICU, medications, and laboratory tests).

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Xiao, Dr.

CONTACT

[email protected]

+86-13810971299

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
May 22, 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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