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Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT02639741
Recruitment Status : Recruiting
First Posted : December 24, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hakki Unlugenc, Cukurova University

Study Description
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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
Postoperative Pain Drug: Melatonin Drug: Vitamin C Other: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia
Study Start Date : November 2014
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
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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 Name: Melatonina 3 mg tb,

Drug: Vitamin C
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
Other Name: Vitamin C 1000 mg tb

Other: Placebo
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
Other Name: Placebo tb
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 Name: Melatonina 3 mg tb,

Drug: Vitamin C
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
Other Name: Vitamin C 1000 mg tb

Other: Placebo
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
Other Name: Placebo tb
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 Name: Melatonina 3 mg tb,

Drug: Vitamin C
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
Other Name: Vitamin C 1000 mg tb

Other: Placebo
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
Other Name: Placebo tb


Outcome Measures
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Primary Outcome Measures :
  1. morphine consumption at 24 hours after surgery.) [ Time Frame: 24 hour ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639741


Contacts
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Contact: Hakkı Ünlügenç, Prof Dr. +905336417891 unlugenc@cu.edu.tr
Contact: Hakkı Ünlügenç, Prof Dr. +903223386742 hunlugenc@cu.edu.tr

Locations
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Turkey
Hakkı Ünlügenç Recruiting
Adana, Turkey, 01330
Contact: Hakkı Ünlügenç, Prof. Dr.    +905336417891    unlugenc@cu.edu.tr   
Sponsors and Collaborators
Cukurova University
Investigators
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Study Director: Hakkı Ünlügenç, Prof Dr. Cukurova University
More Information
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Responsible Party: Hakki Unlugenc, Clinical Professor, Cukurova University
ClinicalTrials.gov Identifier: NCT02639741    
Other Study ID Numbers: HZLTNS99
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hakki Unlugenc, Cukurova University:
Melatonin
Vitamin C
Morphine consumption
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Vitamins
Ascorbic Acid
Melatonin
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants