Comparative Study Between Transdermal Nicotine and Melatonin Patches on Postoperative Pain Relief After Laparoscopic Cholecystectomy, a Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- A Mean Difference of Total Analgesic (Pethidine) Consumption.
研究概览
简要总结
Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •60 female patients.
- •non-smoker patients.
- •aged between 18 and 50 years old.
- •ASA physical status I and II.
- •70-90 kg body weight and height 160-180 cm.
- •undergoing elective laparoscopic cholecystectomy under general anesthesia.
排除标准
- •Patients with impaired kidney or liver functions.
- •history of cardiac or central nervous system disease.
- •history of smoking.
- •history of drug or alcohol abuse.
- •history of chronic pain or daily intake of analgesics.
- •uncontrolled medical disease (diabetes mellitus and hypertension).
- •history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery.
- •allergy to the used medications.
- •coagulation defect.
- •local infection at the site of application of transdermal patch.
- •patient's refusal.
- •duration of surgery more than 120 minutes.
研究组 & 干预措施
C group, (n=20)
C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
干预措施: Placebo (Drug)
TDN group, (n=20)
TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
干预措施: transdermal therapeutic system- nicotine. (Drug)
TDM group, (n=20)
TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
干预措施: transdermal therapeutic system- melatonin. (Drug)
结局指标
主要结局
A Mean Difference of Total Analgesic (Pethidine) Consumption.
时间窗: [Time Frame: The total pethidine requirements (mg) 12 hours postop]
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Dr.
Ain Shams University