Comparing the effects of Melatonin with Alprazolam to reduce anxiety before surgery and pain after surgery in adults undergoing laparoscopic removal of gall bladder under general anaesthesia

COMPARISON OF EFFECTS OF MELATONIN WITH ALPRAZOLAM ON PRE-OPERATIVE ANXIETY IN ADULT PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022358

Enrollment

135

Registered

2019-12-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K819- Cholecystitis, unspecified

Interventions

Intervention1: Melatonin: Melatonin 6mg single dose given orally in Pre operative period 120 minutes before surgery Control Intervention1: Alprazolam: Alprazolam 0.5mg single dose given orally in Pre

Eligibility

Inclusion criteria

Inclusion criteria: 1.American Society of Anaesthesiologists ( ASA) Physical status I and II. 2. Age between 20 to 70 years

Exclusion criteria

Exclusion criteria: 1.Pregnant women 2.Patients with Psychiatric illness 3.Patients on Steroids and Antipsychotics. 4.Conversion to Open Cholecystectomy. 5.Patients with allergy to Melatonin and Alprazolam.

Design outcomes

Primary

Measure	Time frame
To compare the Effect of Melatonin and Alprazolam on pre operative anxiety, sedation and orientation scores.Timepoint: Before medication, 120 mintues after pre medication	—

Secondary

Measure	Time frame
To compare the effect of Melatonin and Alprazolam on post operative analgesic pain scores.Timepoint: At Post operative 0,1,6,12,24 hours.	—

Countries

India

Contacts

Public ContactDr Meghana Ravi

M S Ramaiah Medical College

jageedha@yahoo.com9900482828

Outcome results

None listed

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