Comparing the effects of Melatonin and Alprazolam as pre-medication for anaesthesia

Not yet recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2025/03/082817
• Lead Sponsor: Christian Medical College and Hospital Brown Road Ludhiana Punjab Pin

Brief Summary

**Background:** Preoperative anxiety is a major concern in patients undergoing any surgical procedure. Various drugs have been used to alleviate it. Benzodiazepines are among the most popular preoperative medications because they produce anxiolysis, amnesia and sedation. Melatonin is an endogenous neurohormone secreted by the pineal gland with the unique property of producing anxiolysis with no impairment of cognitive and psychomotor function. However there have been few studies comparing oral alprazolam and oral melatonin.

**Aims and Objectives:** To compare the effects of oral melatonin with oral alprazolam on preoperative anxiety, sedation, and orientation when given as premedication.

To study the side effects of alprazolam and melatonin, if any.

**Materials and Methods:** This prospective, randomized controlled study will be conducted on 80 patients, 40 in each group undergoing elective surgeries under general anaesthesia or spinal anaesthesia. Group A will be for patients receiving Tablet Alprazolam and Group B will be for patients receiving Tablet Melatonin.  On Day 0, i.e. the day of the pre-anaesthetic checkup, the patients’ haemodynamic parameters as well as Visual Analogue Scale for anxiety (VAS-A) score, Ramsay sedation score (RSS) and Orientation Score will be assessed. On Day 1, i.e. the day of surgery, after the administration of drug one hour prior to the surgery, the same parameters will be assessed inside the operation theatre before starting anaesthesia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-17
• Study Start: 2025-04-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All consenting adults who are: 1.Aged between 18-60 years.
• 2.ASA I and II patients planned for elective surgeries under general anaesthesia or spinal anaesthesia anticipated to last more than one hour.
• 3.Patients admitted into the hospital at least a day prior to the planned procedure.

Exclusion Criteria

• 1.Age below 18 years or above 60 years 2.All emergency cases.
• 3.History of allergy to either of the study drugs i.e. Tab.
• Alprazolam and Tab.
• 4.History of drug addiction.
• 5.Patients with psychiatric disorders on medication with benzodiazepenes.
• 6.Patients who are chronic alcoholics or who have consumed alcohol in the 24 hours prior to planned procedure.
• 7.Patients with a BMI of more than 30.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess pre operative anxiety	At the time of pre-a aesthetic check up | One hour prior to shifting to ot

Secondary Outcome Measures

Name	Time	Method
To check for adverse effects of Tab. Alprazolam and Tab. Melatonin	1. During pre anesthetic check up

Trial Locations

Locations (1)

Christian Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Christian Medical College and Hospital

🇮🇳Ludhiana, PUNJAB, India

Dr Melchisedec Singh

Principal investigator

9876620747

msedec@gmail.com