Effect of oral melatonin as premedication on haemodynamic changes during laparoscopic cholecystectomy

Effect of oral melatonin as premedication on haemodynamic changes during laparoscopic cholecystectomy - A randomized double blinded controlled trial - Nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078503

Enrollment

Registered

2024-12-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: oral melatonin: All patients in this group will receive oral melatonin tablet in a dose of 5 mg, 2 hours before induction of general anesthesia. Control Intervention1: oral multi-vitami

Eligibility

Inclusion criteria

Inclusion criteria: 20-60 years old ASA category I and II BMI more than 18.5 and BMI less than 29.9 Patients undergoing elective cholecystectomy

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with diabetes, hypertension, obesity, valvular heart disease, renal and hepatic impairment. Patients on anticoagulants and antiplatelets. Patients on other sedative hypnotic drugs. Patients on antipsychotics, anxiolytics and antiepileptic. Patients with sleep disorders. Patients with known drug allergy. Patients on oral contraceptives, caffeine, fluvoxamine, oral hypoglycemic agents, immunosuppressants. Patients on calcium channel blockers. Patients with anticipated difficult airway. Pregnant patients. Contraindication to general anesthesia. Patients anticipated to have surgical complications.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of oral melatonin on hemodynamic parameters which include heart rate, mean arterial pressure, systolic and diastolic blood pressure during intra-operative and post-operative up to 24 hours after surgery, in patients undergoing laparoscopic cholecystectomy under general anesthesiaTimepoint: 5 mins after intubation, 10 mins after intubation, before pneumoperitoneum, 5 mins after pneumoperitoneum till 30 mins after pneumoperitoneum and then after every 10 mins till patient is extubated. 1hr, 4hr, 8hr, 12hr,24hr, 36hr,48hr	—

Measure

Time frame

To evaluate the effect of oral melatonin on hemodynamic parameters which include heart rate, mean arterial pressure, systolic and diastolic blood pressure during intra-operative and post-operative up to 24 hours after surgery, in patients undergoing laparoscopic cholecystectomy under general anesthesiaTimepoint: 5 mins after intubation, 10 mins after intubation, before pneumoperitoneum, 5 mins after pneumoperitoneum till 30 mins after pneumoperitoneum and then after every 10 mins till patient is extubated. 1hr, 4hr, 8hr, 12hr,24hr, 36hr,48hr

—

Secondary

Measure	Time frame
To evaluate the effect of oral melatonin on post-operative sedation score, visual analogue score for post operative pain and rescue analgesics received postoperatively up to 24 hours after surgery.Timepoint: 1hour, 4hour, 8 hour, 12hour,24hour, 36 hour, 48 hour	—

Countries

India

Contacts

Public ContactDr. Deepanshu Dhiman

Dr. yashwant sing parmar government medical collge and hospital , Nahan

panshu88@gmail.com9646308822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026