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Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Melatonin

Vitamin C

Placebo

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Melatonin, Vitamin C, Morphine consumption

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hakkı Ünlügenç

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Melatonin Tablet

Oral Vitamin C Tablet

Oral Placebo Tablet

Arm Description

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.

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.

Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.

Outcomes

Primary Outcome Measures

morphine consumption at 24 hours after surgery.)

Secondary Outcome Measures

Full Information

NCT ID

NCT02639741

First Posted

November 11, 2015

Last Updated

August 6, 2021

Sponsor

Cukurova University

1. Study Identification

Unique Protocol Identification Number

NCT02639741

Brief Title

Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cukurova University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Melatonin, Vitamin C, Morphine consumption

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Melatonin Tablet

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Oral Vitamin C Tablet

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Oral Placebo Tablet

Arm Type

Placebo Comparator

Arm Description

Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.

Intervention Type

Drug

Intervention Name(s)

Melatonin

Other Intervention Name(s)

Melatonina 3 mg tb,

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vitamin C

Other Intervention Name(s)

Vitamin C 1000 mg tb

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo tb

Intervention Description

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

Primary Outcome Measure Information:

Title

morphine consumption at 24 hours after surgery.)

Time Frame

24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hakkı Ünlügenç, Prof Dr.

Organizational Affiliation

Cukurova University

Official's Role

Study Director

Facility Information:

Facility Name

Hakkı Ünlügenç

City

Adana

ZIP/Postal Code

01330

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

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