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Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Sponsor
Cukurova University (Other)
Overall Status
Completed
CT.gov ID
NCT02639741
Collaborator
(none)
55
Enrollment
1
Location
3
Arms
74
Duration (Months)
0.7
Patients Per Site Per Month

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

Study Type:
Interventional
Actual 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 :
Nov 1, 2014
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Dec 30, 2020

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:
  • Melatonina 3 mg tb,

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

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

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

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

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. morphine consumption at 24 hours after surgery.) [24 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    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

    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.
    Responsible Party:
    Hakki Unlugenc, Clinical Professor, Cukurova University
    ClinicalTrials.gov Identifier:
    NCT02639741
    Other Study ID Numbers:
    • HZLTNS99
    First Posted:
    Dec 24, 2015
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Hakki Unlugenc, Clinical Professor, Cukurova University
    Melatonin
    Vitamin C
    Morphine consumption
    Additional relevant MeSH terms:
    Pain, Postoperative
    Vitamins
    Ascorbic Acid
    Melatonin

    Study Results

    No Results Posted as of Aug 9, 2021