Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Study 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.

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

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Melatonin
* Drug: Vitamin C
* Other: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Melatonin Tablet<br>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<br>* Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Melatonina 3 mg tb,;Drug: Vitamin C<br>* Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Vitamin C 1000 mg tb;Other: Placebo<br>* Preoperative placebo tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Placebo tb;|
| Active Comparator: Oral Vitamin C Tablet<br>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<br>* Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Melatonina 3 mg tb,;Drug: Vitamin C<br>* Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Vitamin C 1000 mg tb;Other: Placebo<br>* Preoperative placebo tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Placebo tb;|
| Placebo Comparator: Oral Placebo Tablet<br>Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia. | Drug: Melatonin<br>* Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Melatonina 3 mg tb,;Drug: Vitamin C<br>* Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Vitamin C 1000 mg tb;Other: Placebo<br>* Preoperative placebo tablet will be given and postoperative pain scores will be evaluated<br>* Other names: Placebo tb;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption at 24 hours after surgery.) |  | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin, Vitamin C, Morphine consumption