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NCT Number: NCT02639741

Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hakkı Ünlügenç

Adana, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated

Other names: Melatonina 3 mg tb,

Vitamin C

Drug

Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated

Other names: Vitamin C 1000 mg tb

Placebo

Other

Preoperative placebo tablet will be given and postoperative pain scores will be evaluated

Other names: Placebo tb

Primary outcomes

  1. morphine consumption at 24 hours after surgery.)

    Time frame: 24 hour

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2015
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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