Xuanwu Hospital, Capital Medical University
Beijing, China
Location status: Recruiting
NCT Number: NCT07479446
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Beijing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 to 48 hours after surgery
Defined as the subjective feeling of wanting to vomit, lasting ≥5 minutes.
Time frame: Within 48 hours after surgery
Assessed using the Verbal Rating Scale (VRS, 0-10) at rest and during movement.
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.
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).
Time frame: Within 48 hours after surgery.
Frequency and/or dose of administered rescue antiemetics (e.g., 5HT-3 receptor antagonists, metoclopramide).
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.
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.
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.
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.
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).
Time frame: Preoperative and on postoperative days 1-2.
Changes in levels of Pepsinogen I, Pepsinogen II, Gastrin-17, and Serotonin (5-HT).
Time frame: Within 48 hours after surgery.
Total amount of study drug used via PCIA pump, converted to morphine milligram equivalents (MME).
Time frame: Within 48 hours after surgery.
Number of effective demands and total number of demands.
Time frame: Within 48 hours after surgery.
Frequency and/or dose of administered rescue analgesics (e.g., NSAIDs).
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).
Time frame: Within 48 hours after surgery.
Defined as respiratory rate < 10 breaths/min or SpO₂ < 90% for >1 min, or PaCO₂ > 50 mmHg.
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
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.
Time frame: Within 48 hours after surgery.
Assessed using a Visual Analogue Scale (VAS, 0-10).
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).
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.
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.
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.
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).
Contact information is provided by the study sponsor or research team.
Xuanwu Hospital, Beijing
Other
Comparative Study of Oliceridine Versus Sufentanil for Patient-Controlled Intravenous Analgesia in Improving Postoperative Nausea in Patients Undergoing Cerebellopontine Angle Region Surgery.
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