MedPath

A study on the effects of commonly used pre operative anxiety reducing medicines midazolam and melatonin on cognition and psychomotor function

Phase 1
Completed
Conditions
Medical and Surgical, (2) ICD-10 Condition: N218||Other lower urinary tract calculus,
Registration Number
CTRI/2021/07/035284
Lead Sponsor
Dr S SreeRanjini
Brief Summary

Anxiety before surgery occurs commonly and if untreated, can lead to intra and post operative hemodynamic issues due to sympathetic overdrive, as well as higher chances of infection and delayed wound healing. Hence pre operative anxiolytic medications have to be given. But all these anxiolytics have effects on the cognition and psychomotor function; which can be detrimental in daycare surgery,older patients and susceptible population. So in this study, we plan to study the effects of commonly used anxiolytics namely midazolam (oral and intranasal) and melatonin (oral and orobuccal) in standard doses and their effect on neurocognitive and psychomotor functions. The hypothesis being oral melatonin will have the least effects on neurocognitive and psychomotor functions when compared to midazolam in any route.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
165
Inclusion Criteria

Adult Patients of ASA – PS classification I and II status between 18 – 60 years of age undergoing any surgery requiring anaesthesia, education high school and above.

Exclusion Criteria

Patients with ASA – PS classification III physical status or greater, Patients less than 18 years of age and more than 60 years of age, Unwilling patients, patients with psychiatric disorders on anti psychotic drugs, language or communication difficulties, sleep disorders, renal or hepatic derangement, low intelligence quotient, abnormalities of the right and left hands and inability to read and write basic alphabets,obstetric.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sedationbaseline status checked, that is before drug administration and rechecked one hour after drug administration
Orientationbaseline status checked, that is before drug administration and rechecked one hour after drug administration
Amnesiabaseline status checked, that is before drug administration and rechecked one hour after drug administration
Cognitive and psychomotor dysfunctionbaseline status checked, that is before drug administration and rechecked one hour after drug administration
Secondary Outcome Measures
NameTimeMethod
•Anxiolysis•Adverse effects such as nausea, vomiting, hemodynamic disturbances etc

Trial Locations

Locations (1)

Bhaarath medical college

🇮🇳

Kancheepuram, TAMIL NADU, India

Bhaarath medical college
🇮🇳Kancheepuram, TAMIL NADU, India
DrSreeRanjini
Principal investigator
9840770817
anaesthesiology@bmch.ac.in

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.