Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- morphine consumption at 24 hours after surgery.)
研究概览
简要总结
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery.
详细描述
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery. One hundred-sixty five ASA I-II adult patients between 18-65 years of age, undergoing elective major abdominal surgery with general anesthesia will be included in this double blinded, randomised, controlled study. Patients will randomly divided into equal (n=55) three groups. Preoperatively, one hour before surgery, patients will receive melatonin (6 mg) in group M, vitamin C (2 gr) in group C or placebo tablet in group P orally. A standard anesthetic protocol will be administered to all patients. At the end of surgery, postoperative pain control will be provided via a patient controlled analgesia (PCA) device including morphine in all groups. Hemodynamic parameters, pain, sedation, patient satisfaction, total morphine consumption, supplement analgesic requirement, incidence of nausea and vomiting and other side effects will be recorded at 5, 10, 30 min and 1, 2, 4, 6, 8, 12, 24 hr after surgery.
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, Investigator)
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
- •Patients undergoing elective major abdominal surgery with general anesthesia
排除标准
- •A history of psychiatric disorders, chronic pain syndromes, obstructive sleep apnea, severe asthma, chronic obstructive pulmonary disease, congestive heart failure, hepatic or renal failure, patients with pregnancy or in lactation period or a history of allergic reaction to any drugs
研究组 & 干预措施
Oral Melatonin Tablet
Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia.
干预措施: Melatonin (Drug)
Oral Melatonin Tablet
Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia.
干预措施: Vitamin C (Drug)
Oral Melatonin Tablet
Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia.
干预措施: Placebo (Other)
Oral Vitamin C Tablet
Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia.
干预措施: Melatonin (Drug)
Oral Vitamin C Tablet
Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia.
干预措施: Vitamin C (Drug)
Oral Vitamin C Tablet
Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia.
干预措施: Placebo (Other)
Oral Placebo Tablet
Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.
干预措施: Melatonin (Drug)
Oral Placebo Tablet
Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.
干预措施: Vitamin C (Drug)
Oral Placebo Tablet
Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.
干预措施: Placebo (Other)
结局指标
主要结局
morphine consumption at 24 hours after surgery.)
时间窗: 24 hour
次要结局
未报告次要终点
研究者
Hakki Unlugenc
Clinical Professor
Cukurova University