NCT06304181尚未招募不适用
Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy
The Fourth Affiliated Hospital of Zhejiang University School of Medicine0 个研究点目标入组 90 人开始时间: 2024年3月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- NRS scores
研究概览
简要总结
This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obtain informed consent；
- •Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia；
- •Classified as American Society of Anesthesiologists (ASA) physical status I~II；
- •Age over 18 years；
- •Patients voluntarily participate and sign the informed consent form
排除标准
- •Systolic blood pressure ≥180 mm Hg or <90 mm Hg, diastolic blood pressure ≥110 mm Hg or <60 mmHg
- •heart rate <50 beats/min；
- •Patients with severe liver or kidney dysfunction (severe liver dysfunction: ALT, conjugated bilirubin, AST, ALP, total bilirubin any one >2 times the upper limit of normal
- •severe kidney dysfunction: creatinine clearance <60 ml/min)；
- •Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)；
- •Patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease；
- •History of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse；
- •Neuromuscular diseases；
- •Tendency towards malignant hyperthermia；
- •Allergy to the study drug or other contraindications；
- •Participation in another drug clinical trial within the past 30 days；
- •Any cerebrovascular accidents such as stroke, transient ischemic attack (TIA) in the last 3 months；
- •Unstable angina, myocardial infarction in the last 3 months；
- •Undergone another surgery within the last 3 months；
- •Coagulopathy
研究组 & 干预措施
Paracetamol and Mannitol Injection group
Experimental
Paracetamol and Mannitol Injection 500mg was given intravenously 30 minutes before the end of the operation
干预措施: Paracetamol and Mannitol Injection (Drug)
Parecoxib group
Active Comparator
40mg of parecoxib was given intravenously 30min before the end of the operation
干预措施: Parecoxib (Drug)
结局指标
主要结局
NRS scores
时间窗: after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
NRS scores at rest and during movement (coughing) after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
RASS score
时间窗: after extubation 10 (±5) minutes and 24 hours after surgery
RASS score after extubation 10 (±5) minutes and 24 hours after surgery
次要结局
- Total analgesic pump drug use(From the end of surgery until removal of the analgesic pump,assessed up to 3 days)
- Time of first use of remedial analgesics or analgesic pump(From the end of surgery until the date of first use of remedial analgesics or analgesic pumps,assessed up to 3 days)
- Postoperative bilirubin level(Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery))
- Postoperative creatinine level(Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery))
- Postoperative liver enzyme level(Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery))
- Postoperative cortisol level(Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery))
- Postoperative IL-6 level(Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery))
- Postoperative IL-8 level(Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery))
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