Investigating the Effect of Subanesthetic Doses of Nalbuphine Combined With Remimazolam in Patients Undergoing Arthroscopic Knee Surgery for Knee Joint Injuries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain measured by the Visual Analog Scale (retrospectively designated)
研究概览
简要总结
This study compared two combinations of medicines used for sedation and pain relief in adults undergoing knee arthroscopy for knee joint injuries. One group received nalbuphine with remimazolam, and the other received nalbuphine with propofol. The study examined pain, sedation, cognitive function, and adverse events. A total of 100 adults aged 18 to 65 years were randomly assigned to the two groups, with 50 participants in each group. All participants underwent surgery under combined spinal-epidural anesthesia. Pain, sedation, and cognitive function were assessed immediately after surgery and at 6, 12, and 24 hours after surgery.
详细描述
This single-center, randomized, parallel-group study was conducted at Wuhan Fourth Hospital. Participants were assigned using a random-number table. Both groups were managed by the same anesthesia team. Intraoperative assessments included blood pressure, heart rate, respiratory rate, oxygen saturation, anesthesia induction time, anesthesia duration, and awakening time. Postoperative assessments included the Visual Analog Scale for pain, the Ramsay Sedation Scale, and the Mini-Mental State Examination. Adverse events assessed included hypotension, respiratory depression, bradycardia, postoperative agitation, nausea and vomiting, pruritus, chills, and diplopia. The study was approved by the Wuhan Fourth Hospital ethics committee, and participants provided written informed consent before surgery.
No primary outcome measure was prespecified before the study began. This registration is being prepared after study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Postoperative pain, sedation, and cognitive function scores were assessed by Qian Xu, who was unaware of the assigned drug regimen.
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
- •Knee joint injury diagnosed by clinical and imaging examinations, with planned knee arthroscopy.
- •Age 18 to 65 years.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Normal preoperative cognitive function, with Mini-Mental State Examination (MMSE) score >=
- •No long-term preoperative use of analgesic, sedative, or antipsychotic medication.
排除标准
- •Psychiatric disorders, including depression, anxiety, or schizophrenia, or neurological disorders, including Parkinson disease, epilepsy, or post-stroke sequelae.
- •Allergy to nalbuphine, remimazolam, or related medications.
- •Severe hepatic or renal impairment, including cirrhosis or chronic renal failure, or uncontrolled hypertension or diabetes mellitus.
- •Considered unsuitable for participation by the investigators.
- •Serious intraoperative complications, including anesthesia accidents or massive intraoperative bleeding, or withdrawal during the study (post-enrollment exclusion or withdrawal criteria).
研究组 & 干预措施
Nalbuphine With Remimazolam
50 participants received nalbuphine 0.1 mg/kg and remimazolam 0.2-0.3 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of remimazolam 0.05 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia.
干预措施: Nalbuphine (Drug)
Nalbuphine With Remimazolam
50 participants received nalbuphine 0.1 mg/kg and remimazolam 0.2-0.3 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of remimazolam 0.05 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia.
干预措施: Remimazolam (Drug)
Nalbuphine With Propofol
50 participants received nalbuphine 0.1 mg/kg and propofol 1.5-2.0 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of propofol 0.5 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia.
干预措施: Propofol (Drug)
Nalbuphine With Propofol
50 participants received nalbuphine 0.1 mg/kg and propofol 1.5-2.0 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of propofol 0.5 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia.
干预措施: Nalbuphine (Drug)
结局指标
主要结局
Postoperative pain measured by the Visual Analog Scale (retrospectively designated)
时间窗: Immediately after surgery and at 6, 12, and 24 hours after surgery
Postoperative pain intensity assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Lower scores indicate less pain. Scores are compared between the two treatment groups at each specified assessment. No primary outcome was prespecified before the study began. This measure is designated as primary for this retrospective registration after study completion; it was not a prospectively specified primary endpoint.
次要结局
- Postoperative sedation measured by the Ramsay Sedation Scale(Immediately after surgery and at 6, 12, and 24 hours after surgery)
- Postoperative Mini-Mental State Examination score(Immediately after surgery and at 6, 12, and 24 hours after surgery)
- Incidence of postoperative agitation(From the end of surgery through 24 hours after surgery)
- Incidence of postoperative nausea and vomiting(From the end of surgery through 24 hours after surgery)
- Incidence of intraoperative hypotension(During surgery)
- Incidence of intraoperative respiratory depression(During surgery)
- Incidence of bradycardia(During the perioperative observation period, through 24 hours after surgery)
- Incidence of pruritus, chills, and diplopia(During the perioperative observation period, through 24 hours after surgery)
- Intraoperative blood pressure(During surgery)
- Intraoperative heart rate(During surgery)
- Intraoperative respiratory rate(During surgery)
- Intraoperative oxygen saturation(During surgery)
- Anesthesia induction time(During anesthesia induction on the day of surgery)
- Duration of anesthesia(During anesthesia on the day of surgery)
- Awakening time(During recovery from anesthesia on the day of surgery)
- Postoperative cognitive impairment based on the manuscript MMSE threshold(Immediately after surgery and at 6, 12, and 24 hours after surgery)
研究者
Zhang Zhou
Principal Investigator
Wuhan Fourth Hospital