Series Study on the Application of G Protein-Biased Receptor Agonist Oliceridine in Gynecological Surgery (2)：Effects of Oliceridine Versus Sufentanil on Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting(PONV)
研究概览
简要总结
The aim of this clinical trial is to evaluate the impact of the analgesic Oliceridine on postoperative nausea and vomiting (PONV) following gynecological laparoscopic surgery. It will also assess the safety profile of Oliceridine. The trial seeks to address the following key questions:
Can Oliceridine reduce the incidence of postoperative nausea and vomiting (PONV) in gynecological laparoscopic surgery? Does the incidence of PONV differ between patients receiving Oliceridine and those receiving the commonly used analgesic sufentanil in gynecological laparoscopic surgery? Are there any opioid-related adverse reactions in gynecological laparoscopic surgery patients using Oliceridine?
Participants will:
Receive Oliceridine or sufentanil for anesthesia induction, maintenance, and postoperative pain management.
Vital signs during surgery and the occurrence of postoperative nausea and vomiting will be recorded.
Be followed up for at least 48 hours.
详细描述
Study Design:
This randomized, double-blind, parallel-controlled trial compares oliceridine versus sufentanil for anesthesia/analgesia in gynecologic laparoscopy at Second Xiangya Hospital. The study features:
- Randomization: Computer-generated 1:1 allocation via sealed envelopes
- Blinding: Triple-blinding (participants, clinicians, outcome assessors) maintained through: Identical drug preparations (volume/appearance-matched);Separation between anesthesia nurses preparing drugs and clinical/research teams
- Control: Active comparator (sufentanil) reflecting current standard practice.
Technical Methodology：
- Anesthesia Protocol: Standardized induction with midazolam (0.05-0.10 mg/kg), study drug (sufentanil 0.3 μg/kg vs oliceridine 0.06 mg/kg), propofol (1.5-2.0 mg/kg), and cisatracurium (0.2-0.3 mg/kg). Maintenance via TIVA: propofol (4-10 mg/kg/h) + remifentanil (0.1-0.2 μg/kg/min). Pre-incision/closure boluses: Study drug dosed per group (sufentanil 0.1-0.2 μg/kg vs oliceridine 0.02-0.04 mg/kg).
- Analgesia Management: PCA pump configuration: Sufentanil group: 2 μg/kg in 100 mL NS; Oliceridine group: 0.4 mg/kg in 100 mL NS; Fixed adjuncts: ondansetron 8 mg + dexamethasone 10 mg.Demand dose: 2 mL (lockout 10 min), max 10 mL/h.
- Rescue Protocols: Analgesia: Sufentanil 5 μg or oliceridine 0.2 mg IV PRN; PONV: Ondansetron 4 mg + dexamethasone 5 mg; haloperidol 1 mg if refractory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective gynecological laparoscopic surgery;
- •Age 18-65 years;
- •ASA physical status I-III;
- •Body mass index (BMI) 18-30 kg/m².
排除标准
- •Severe dysfunction of major organs such as the heart, lungs, or brain;
- •History of allergy to opioid drugs, propofol, soybeans, or eggs;
- •Recent use of sedatives, analgesics, or monoamine oxidase inhibitors;
- •History of alcohol abuse;
- •Obstructive sleep apnea syndrome;
- •Difficult airway;
- •Psychiatric or neurological disorders; communication disorders;
- •Women who are lactating or pregnant.
- •Withdrawal criteria:
- •Subject requests withdrawal or withdraws voluntarily;
- •Change in surgical method requiring combined gastrointestinal surgery;
- •Occurrence of allergy to the investigational drug or life-threatening complications;
- •Reoperation within 48 hours postoperatively due to bleeding or other factors.
研究组 & 干预措施
Oliceridine group
Anesthesia and analgesia with Oliceridine
干预措施: Oliceridine (Drug)
Sufentanil group
Anesthesia and analgesia with sufentanil
干预措施: Sufentanil (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting(PONV)
时间窗: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
PONV will be assessed within 48 hours postoperatively in the ward by a blinded investigator. Subjects are required to use the simplified PONV impact scale to report whether any PONV events occurred in the past 48 hours and to provide a rating. (Q1. Have you experienced vomiting or symptoms of vomiting? If yes, how many episodes in total? Under what circumstances did it occur? Was any medication administered for treatment? Q2. Have you experienced nausea? If yes, did the sensation of nausea affect your daily activities? Was any medication administered for treatment?) Mild PONV is defined as mild nausea or a single vomiting episode caused by water or physical activity. Moderate PONV includes two vomiting episodes or significant nausea needing rescue therapy. Severe PONV is more than two vomiting episodes or requiring multiple doses of rescue therapy. Absence of symptoms requiring treatment is considered complete remission.
Incidence of postoperative nausea and vomiting(PONV)
时间窗: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
PONV will be assessed within 48 hours postoperatively in the ward by a blinded investigator. Subjects are required to use the simplified PONV impact scale to report whether any PONV events occurred in the past 48 hours and to provide a rating. (Q1. Have you experienced vomiting or symptoms of vomiting? If yes, how many episodes in total? Under what circumstances did it occur? Was any medication administered for treatment? Q2. Have you experienced nausea? If yes, did the sensation of nausea affect your daily activities? Was any medication administered for treatment?) Mild PONV is defined as mild nausea or a single vomiting episode caused by water or physical activity. Moderate PONV includes two vomiting episodes or significant nausea needing rescue therapy. Severe PONV is more than two vomiting episodes or requiring multiple doses of rescue therapy. Absence of symptoms requiring treatment is considered complete remission.
次要结局
- Incidence of postoperative vomiting (POV) postoperative 48 hours(From the time of awakening to 48 hours postoperatively. Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.)
- Rescue antiemetic medications(From awakening to 48 hours postoperatively)
- Postoperative Visual Analog Scale (VAS) score(From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.)
- Ramsay sedation score(Postoperative 2 hours)
- Sleep quality score(At the night of the surgery day, Day 0)
- Quality of Recovery-15 (QOR-15) score(Preoperative, postoperative day 1, and postoperative day 3, respectively)
- The time of the first postoperative bowel gas passage(From end of surgery until first postoperative passing of gas, assessed up to 72 hours.)
- Time staying in the PACU(From PACU arrival until discharge, assessed up to 6 hours.)
- Intraoperative hypotension(From anesthesia induction until PACU discharge, assessed up to 6 hours.)
- Incidence of postoperative vomiting (POV) postoperative 48 hours(From the time of awakening to 48 hours postoperatively. Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.)
- Postoperative Visual Analog Scale (VAS) score(From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.)
- Ramsay sedation score(Postoperative 2 hours)
- Rescue antiemetic medications(From awakening to 48 hours postoperatively)
- Sleep quality score(At the night of the surgery day, Day 0)
- Quality of Recovery-15 (QOR-15) score(Preoperative, postoperative day 1, and postoperative day 3, respectively)
- Time staying in the PACU(From PACU arrival until discharge, assessed up to 6 hours.)
- The time of the first postoperative bowel gas passage(From end of surgery until first postoperative passing of gas, assessed up to 72 hours.)
- Intraoperative hypotension(From anesthesia induction until PACU discharge, assessed up to 6 hours.)
研究者
YanYing Xiao
Associate Professor of the Department of Anesthesiology, the Second Xiangya Hospital, Central south University
Second Xiangya Hospital of Central South University