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effect of melatonin on inflammatory factors and pain in patients undergoing elective laparoscopic cholecystectomy

effect of melatonin on inflammatory factors and pain in patients undergoing elective laparoscopic cholecystectomy.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250814066851N1
Enrollment
70
Registered
2025-09-24
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients after laparoscopic cholecystectomy. Cholecystitis, unspecified

Interventions

Intervention 1: Intervention group: Patients receive a 5 mg melatonin tablet (manufactured by Daneshpajoohan Arian Daru Company, Iran) one hour before the procedure. Intervention 2: Control group: Pat

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 65 years with ASA I - II Patients who will undergo elective laparoscopic cholecystectomy at Shahid Mohammadi Hospital

Exclusion criteria

Exclusion criteria: Patients undergoing emergency cholecystectomy. Patients with systemic inflammatory response syndrome History of any rheumatological or inflammatory disease Pregnant or breastfeeding patients Patients with a history of sensitivity to melatonin Patients with alcohol or drug abuse Patients with any liver disease Patients with heart, kidney and liver failure Use of narcotics up to 12 hours before the intervention Patients with hemodynamic instability Patients who require laparotomy during surgery Patients treated with systemic corticosteroids

Design outcomes

Primary

MeasureTime frame
Reduce postoperative pain with minimal complications. Timepoint: Pain intensity will be measured and recorded at 1, 6, 12, and 24 hours after surgery. Method of measurement: Pain intensity will be measured with a visual analog scale.;Reduce postoperative inflammation with minimal complications. Timepoint: To assess the effect of melatonin on inflammatory factors, blood samples will be collected from eligible patients undergoing laparoscopic cholecystectomy for complete blood count, erythrocyte sedimentation rate, C-reactive protein, liver function tests, and amylase before and 24 hours after surgery. Method of measurement: to assess the effect of melatonin on inflammatory factors, blood samples will be collected from eligible patients undergoing laparoscopic cholecystectomy for complete blood count, erythrocyte sedimentation rate, C-reactive protein, liver function tests, and amylase.

Secondary

MeasureTime frame
Erythrocyte sedimentation rate. Timepoint: Before surgery and 24 hours after surgery. Method of measurement: Measuring the erythrocyte sedimentation rate in a patient's blood sample.;C reactive protein. Timepoint: Before surgery and 24 hours after surgery. Method of measurement: Measuring its level in a patient's blood sample.;Complete blood count. Timepoint: Before surgery and 24 hours after surgery. Method of measurement: Measuring its level in a patient's blood sample.;Liver function test. Timepoint: Before surgery and 24 hours after surgery. Method of measurement: Measuring its level in a patient's blood sample.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdie Rahrovani

Bandare-abbas University of Medical Sciences

rahrovanimahdie@gmail.com+98 76 3368 3699

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026