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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oliceridine | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Xiao, Dr. | Contact | +86-13810971299 | kitten15@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
| 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. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |