Evaluation of Melatonin as a Premedication in patients Undergoing laparoscopic cholecystectomy

EFFECT OF MELATONIN PREMEDICATION IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMIZED, SINGLE BLIND AND PLACEBO-CONTROLLED STUDY - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110311

Enrollment

180

Registered

2026-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis

Interventions

Intervention1: Melatonin as a premedication for patients undergoing laparoscopic cholecystectomy.: Preoperative anxiety constitutes a frequent and clinically significant challenge in surgical practice

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA 1.Patients aged 18 to 65 years. 2.Either sex 3.Scheduled for elective laparoscopic cholecystectomy. 4.Willing to give informed consent. 5.ASA physical status one and two. 6.BMI less than 35.0 kg per meter square

Exclusion criteria

Exclusion criteria: 1.Age less than 18 and more than 65 years 2.ASA physical status three or four. 3.BMI greater than 35.0 kg per meter square 4.Known allergy to melatonin 5.Hepatic, renal or cardiac insufficiency 6.Alcohol or Illicit drug abuse 7.Cognitive impairment or known history of delirium. 8.Patients with psychiatric disorders or on sedatives or on antidepressants. 9.Chronic pain conditions or opioid use.

Design outcomes

Primary

Measure	Time frame
Preoperative anxiety score measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) after melatonin premedication has been administered.Timepoint: 0 and 60 minutes	—

Secondary

Measure	Time frame
Postoperative pain score measured using the Numeric Rating Scale (NRS)Timepoint: 0, 1, 4, 6, 12 and 24 hours postoperatively;Sedation score measured using the Ramsay Sedation scale.Timepoint: Baseline, pre-induction, on arrival to PACU, and at 1, 4, 6, 12 and 24 hours postoperatively;Incidence and severity of postoperative delirium measured using the 4AT (4 A s Test)Timepoint: 0, 1, 4, 6, 12 and 24 hours postoperatively	—

Measure

Time frame

Postoperative pain score measured using the Numeric Rating Scale (NRS)Timepoint: 0, 1, 4, 6, 12 and 24 hours postoperatively;Sedation score measured using the Ramsay Sedation scale.Timepoint: Baseline, pre-induction, on arrival to PACU, and at 1, 4, 6, 12 and 24 hours postoperatively;Incidence and severity of postoperative delirium measured using the 4AT (4 A s Test)Timepoint: 0, 1, 4, 6, 12 and 24 hours postoperatively

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Countries

India

Contacts

Public ContactPRANAY GARG

DEPARTMENT OF ANAESTHESIA, FORTIS HOSPITAL, NOIDA

anutam.rai@fortishealthcare.com9810402906

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026