Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

NCT02639741 | Completed Phase 4

• 1 other identifier: HZLTNS99
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Melatonin; Vitamin C; Morphine consumption

Outcome Measures

Primary Outcomes (1)

• morphine consumption at 24 hours after surgery.)

  24 hour

Study Arms (3)

Oral Melatonin Tablet

ACTIVE COMPARATOR

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; Drug: Vitamin C; Other: Placebo

Oral Vitamin C Tablet

ACTIVE COMPARATOR

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; Drug: Vitamin C; Other: Placebo

Oral Placebo Tablet

PLACEBO COMPARATOR

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

Drug: Melatonin; Drug: Vitamin C; Other: Placebo

Interventions

Melatonin DRUG

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

Also known as: Melatonina 3 mg tb,

Oral Melatonin Tablet; Oral Placebo Tablet; Oral Vitamin C Tablet

Vitamin C DRUG

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

Also known as: Vitamin C 1000 mg tb

Oral Melatonin Tablet; Oral Placebo Tablet; Oral Vitamin C Tablet

Placebo OTHER

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

Also known as: Placebo tb

Oral Melatonin Tablet; Oral Placebo Tablet; Oral Vitamin C Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective major abdominal surgery with general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Hakkı Ünlügenç

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Melatonin; Ascorbic Acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Hakkı Ünlügenç, Prof Dr.

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: December 24, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: December 30, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)