Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cukurova University
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- morphine consumption at 24 hours after surgery.)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing elective major abdominal surgery with general anesthesia
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Placebo (Other)
Oral Placebo Tablet
Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.
Intervention: Melatonin (Drug)
Oral Placebo Tablet
Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.
Intervention: Vitamin C (Drug)
Oral Placebo Tablet
Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
morphine consumption at 24 hours after surgery.)
Time Frame: 24 hour
Secondary Outcomes
No secondary outcomes reported
Investigators
Hakki Unlugenc
Clinical Professor
Cukurova University