Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT02639741
- Lead Sponsor
- Cukurova University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Patients undergoing elective major abdominal surgery with general anesthesia
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral Melatonin Tablet Placebo 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. Oral Vitamin C Tablet Melatonin 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. Oral Vitamin C Tablet Placebo 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. Oral Melatonin Tablet Melatonin 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. Oral Placebo Tablet Placebo Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia. Oral Melatonin Tablet Vitamin C 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. Oral Vitamin C Tablet Vitamin C 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. Oral Placebo Tablet Melatonin Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia. Oral Placebo Tablet Vitamin C Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.
- Primary Outcome Measures
Name Time Method morphine consumption at 24 hours after surgery.) 24 hour
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hakkı Ünlügenç
🇹🇷Adana, Turkey