A study on the effects of commonly used pre operative anxiety reducing medicines midazolam and melatonin on cognition and psychomotor function
- 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
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.
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
Name Time Method Sedation baseline status checked, that is before drug administration and rechecked one hour after drug administration Orientation baseline status checked, that is before drug administration and rechecked one hour after drug administration Amnesia baseline status checked, that is before drug administration and rechecked one hour after drug administration Cognitive and psychomotor dysfunction baseline status checked, that is before drug administration and rechecked one hour after drug administration
- Secondary Outcome Measures
Name Time Method •Anxiolysis •Adverse effects such as nausea, vomiting, hemodynamic disturbances etc
Related Research Topics
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Trial Locations
- Locations (1)
Bhaarath medical college
🇮🇳Kancheepuram, TAMIL NADU, India
Bhaarath medical college🇮🇳Kancheepuram, TAMIL NADU, IndiaDrSreeRanjiniPrincipal investigator9840770817anaesthesiology@bmch.ac.in