Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 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. |
Drug: Melatonin
Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
Other Names:
Drug: Vitamin C
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
Other Names:
Other: Placebo
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
Other Names:
|
Active Comparator: 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. |
Drug: Melatonin
Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
Other Names:
Drug: Vitamin C
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
Other Names:
Other: Placebo
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
Other Names:
|
Placebo Comparator: Oral Placebo Tablet Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia. |
Drug: Melatonin
Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
Other Names:
Drug: Vitamin C
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
Other Names:
Other: Placebo
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
Other Names:
|
Outcome Measures
Primary Outcome Measures
- morphine consumption at 24 hours after surgery.) [24 hour]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hakkı Ünlügenç | Adana | Turkey | 01330 |
Sponsors and Collaborators
- Cukurova University
Investigators
- Study Director: Hakkı Ünlügenç, Prof Dr., Cukurova University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HZLTNS99