Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery.

NCT06374771

Postoperative Pain

NOT_YET_RECRUITING NA

Effect of Melatonin on Postoperative Pain After Simple Nephrectomy

NCT06872944

Pain Score (VAS) at 24 h Postoperatively

COMPLETED EARLY_PHASE1

Melatonin in Obese Patients in Laparoscopic Cholecystectomy

NCT06355687

Anesthesia

NOT_YET_RECRUITING NA

Analgesic and Antioxidant Effects of Melatonin in Pediatric Surgery

NCT06724432

Postoperative Pain Oxidative Stress Response

COMPLETED NA

Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.

NCT05728892

Postoperative Pain

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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

Vitamin C

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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

Vitamin C

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Oral Placebo Tablet

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

Group Type PLACEBO_COMPARATOR

Melatonin

Intervention Type DRUG

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

Vitamin C

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin

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

Intervention Type DRUG

Vitamin C

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Melatonina 3 mg tb, Vitamin C 1000 mg tb Placebo tb

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No