A Prospective, Randomized, Controlled, Single-Blind Clinical Trial Comparing the Effects of Propofol, Ciprofol, and Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting within 24 hours after surgery
研究概览
简要总结
This study is designed to compare three sedative medications used during general anesthesia for gallbladder removal surgery (laparoscopic cholecystectomy) and their effects on nausea and vomiting after surgery.
Background Nausea and vomiting after surgery (postoperative nausea and vomiting, PONV) is a common problem, affecting up to 75% of patients undergoing gallbladder surgery. It can cause discomfort, delay recovery, and lead to other complications. Three medications are commonly used to start and maintain anesthesia: propofol, ciprofol, and remimazolam. This study aims to find out which one is associated with the least nausea and vomiting.
Study Design
This is a prospective, randomized, controlled, single-blind clinical trial. A total of 114 adult patients scheduled for elective laparoscopic cholecystectomy at Xi'an Aerospace Hospital will be randomly assigned to one of three groups (38 patients each):
Propofol group Ciprofol group Remimazolam group All patients will receive the same anti-nausea prevention and pain control after surgery, regardless of their group.
Primary Outcome (Main Measure)
The percentage of patients who experience any nausea and/or vomiting within the first 24 hours after surgery.
Secondary Outcomes (Other Measures)
Percentage of patients who experience vomiting within 24 hours after surgery Percentage of patients who experience nausea within 24 hours after surgery Number of nausea, vomiting, and combined PONV episodes within 24 hours Pain level measured on a 0-10 visual analog scale (VAS) at 0, 6, 12, and 24 hours after surgery (0 = no pain, 10 = worst pain imaginable) Highest pain score reported within the first 24 hours after surgery Significance The results will help doctors choose the best sedative medication to reduce nausea and vomiting after gallbladder surgery, especially for patients who are at higher risk, such as women.
详细描述
Background and rationale
Postoperative nausea and vomiting (PONV) is one of the most common complications following general anesthesia, occurring in 20-30% of the general surgical population and up to 53-72% in high-risk patients. PONV causes significant patient discomfort, prolongs post-anesthesia care unit stay, and may lead to complications including fluid and electrolyte imbalance, wound dehiscence, and aspiration pneumonia. Laparoscopic cholecystectomy (LC) is associated with a particularly high incidence of PONV (40-75%) due to the combined effects of pneumoperitoneum, carbon dioxide absorption, and vagal stimulation during visceral traction.
Propofol is the most widely used intravenous anesthetic agent and is known to possess direct antiemetic properties through suppression of the vomiting center and chemoreceptor trigger zone in the area postrema. However, propofol is associated with injection pain, hypotension, respiratory depression, and potential lipid metabolism disturbances. Two newer sedative agents have recently been approved for clinical use in China: ciprofol (HSK3486), a cyclopropyl structural analogue of propofol with approximately 5-fold greater affinity for GABAA receptors, offering reduced injection pain and improved hemodynamic stability; and remimazolam, an ultra-short-acting benzodiazepine acting on GABAA receptors with rapid onset, rapid recovery, minimal hemodynamic effects, and negligible respiratory depression. Its inactive metabolite and reversibility with flumazenil provide additional safety advantages.
To date, no prospective randomized controlled trial has directly compared the effects of propofol, ciprofol, and remimazolam on PONV in patients undergoing LC. This study aims to fill this evidence gap.
Study design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In this single-blind clinical trial, participants were randomly assigned to one of three groups using a computer-generated block randomization sequence. Allocation concealment was achieved using sequentially numbered, sealed, opaque envelopes. An anesthetic nurse who was not involved in the study placed the group assignment information into the corresponding numbered envelope. The person obtaining informed consent and the participants were unaware of the group assignment. The anesthesiologists administering the interventions were not blinded to the group allocation. Outcome assessors, data collectors responsible for postoperative follow-up, and data analysts were blinded to the group assignment throughout the study period.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, either sex American Society of Anesthesiologists (ASA) physical status classification I-III Scheduled for elective laparoscopic cholecystectomy under general anesthesia Able to understand the study protocol and provide written informed consent Not concurrently enrolled in other clinical studies
排除标准
- •Known hypersensitivity to any anesthetic agent used in the study Severe cardiac, pulmonary, hepatic, or renal dysfunction Active systemic infectious disease Psychiatric disorder or use of sedative agents within the preceding two weeks Refusal to participate
研究组 & 干预措施
Propofol Group
Participants in this arm will receive propofol for anesthesia induction and maintenance during elective laparoscopic cholecystectomy. All participants will also receive standardized perioperative care, including prophylactic antiemetics (ondansetron 8 mg and dexamethasone 10 mg), intraoperative analgesia with sufentanil and remifentanil, cisatracurium for neuromuscular blockade, ultrasound-guided transversus abdominis plane (TAP) block with 0.3% ropivacaine, and postoperative patient-controlled intravenous analgesia (PCIA). The primary and secondary outcomes will be assessed within 24 hours after surgery.
干预措施: Propofol (Drug)
Ciprofol Group
Participants in this arm will receive ciprofol, a novel cyclopropyl analogue of propofol, for anesthesia induction and maintenance during elective laparoscopic cholecystectomy. All participants will also receive standardized perioperative care, including prophylactic antiemetics (ondansetron 8 mg and dexamethasone 10 mg), intraoperative analgesia with sufentanil and remifentanil, cisatracurium for neuromuscular blockade, ultrasound-guided transversus abdominis plane (TAP) block with 0.3% ropivacaine, and postoperative patient-controlled intravenous analgesia (PCIA). The primary and secondary outcomes will be assessed within 24 hours after surgery.
干预措施: Ciprofol (Drug)
Remimazolam Group
Participants in this arm will receive remimazolam, an ultra-short-acting benzodiazepine, for anesthesia induction and maintenance during elective laparoscopic cholecystectomy. All participants will also receive standardized perioperative care, including prophylactic antiemetics (ondansetron 8 mg and dexamethasone 10 mg), intraoperative analgesia with sufentanil and remifentanil, cisatracurium for neuromuscular blockade, ultrasound-guided transversus abdominis plane (TAP) block with 0.3% ropivacaine, and postoperative patient-controlled intravenous analgesia (PCIA). The primary and secondary outcomes will be assessed within 24 hours after surgery.
干预措施: Remimazolam (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting within 24 hours after surgery
时间窗: 24 hours after surgery
The proportion of patients who experience nausea and/or vomiting within the first 24 hours after surgery. Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring within 24 hours postoperatively. Severity will be graded according to World Health Organization (WHO) criteria: Grade I, no nausea or retching; Grade II, mild nausea with abdominal discomfort but no vomiting; Grade III, nausea with retching but no expulsion of gastric contents; Grade IV, severe vomiting with expulsion of gastric contents requiring pharmacological intervention. Overall PONV incidence = (Grade II + Grade III + Grade IV cases) / total cases × 100%.
次要结局
- Incidence of Nausea Within 24 Hours After Surgery(24 hours postoperatively)
- Incidence of Vomiting Within 24 Hours After Surgery(24 hours postoperatively)
- Number of Nausea Episodes Within 24 Hours After Surgery(24 hours postoperatively)
- Number of Vomiting Episodes Within 24 Hours After Surgery(24 hours postoperatively)
- Peak Visual Analog Scale (VAS) Pain Score Within 24 Hours After Surgery(24 hours postoperatively)