A clinical study comparing the effect of oral melatonin and oral alprazolam as premedication in patients undergoing surgery under general Aneasthesia.

A Comparative study between oral melatonin and oral alprazolam as premedicants in patients undergoing surgeries under general anaesthesia: A Clinical Trial - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/096795

Enrollment

Registered

2025-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Oral melatonin: Participants in this group will receive oral melatonin 3 mg tablet administered with a sip of water 60 minutes before induction of general anaesthesia. The purpose is to

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex with ASA physical grade 1 and 2 of age group 18 to 60years

Exclusion criteria

Exclusion criteria: Patient with Allergy to study drugs Pregnant women Patient with mental illness Patient on steroids and antipsychotic drugs Patient unable to read or write

Design outcomes

Primary

Measure	Time frame
To see the reduction in perioperative anxiety with the use of melatonin vs alprazolam in patient undergoing elective surgery under general anaesthesia.Timepoint: The study drug will be given 120 minutes before the patient is taken inside the operation theatre at the pre anaesthetic check up room. 1st assessment will be done 120 minutes before the drug is given and 2nd assessment will be done 120 minutes after the drug has been given.	—

Measure

Time frame

To see the reduction in perioperative anxiety with the use of melatonin vs alprazolam in patient undergoing elective surgery under general anaesthesia.Timepoint: The study drug will be given 120 minutes before the patient is taken inside the operation theatre at the pre anaesthetic check up room. 1st assessment will be done 120 minutes before the drug is given and 2nd assessment will be done 120 minutes after the drug has been given.

—

Secondary

Measure	Time frame
To assess the hemodynamic parameters and evaluate the effects of melatonin and alprazolam on sedation cognition psychomotor function and patients satisfaction in the perioperative period.Timepoint: 60 minutes after administration of premedication and before induction of Aneasthesia.	—

Countries

India

Contacts

Public ContactDr Anita N Devi

Regional institute of medical sciences imphal

dranitadevin@gmail.com8787458045

Outcome results

None listed

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