NCT02639741

Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Melatonin	Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
DRUG	Vitamin C	Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
OTHER	Placebo	Preoperative placebo tablet will be given and postoperative pain scores will be evaluated

Timeline

• Start date: 2014-11-01
• Primary completion: 2020-01-01
• Completion: 2020-12-30
• First posted: 2015-12-24
• Last updated: 2021-08-09

Locations

1 site across 1 country: Turkey (Türkiye)