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

A triple blinded randomised controlled trial on neurocognitive and psychomotor effects of melatonin versus midazolam when administered as preanaesthetic medication before surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035284
Enrollment
165
Registered
2021-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: N218- Other lower urinary tract calculus

Interventions

Intervention1: oral midazolam, nasal midazolam, orobuccal melatonin, placebo sterile water oral: one of the above drugs in standard dosage are given to the patient according to the group allocated onl

Sponsors

Dr S SreeRanjini
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult Patients of ASA ââ?¬â?? PS classification I and II status between 18 ââ?¬â?? 60 years of age undergoing any surgery requiring anaesthesia, education high school and above

Exclusion criteria

Exclusion criteria: Patients with ASA ââ?¬â?? 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

Design outcomes

Primary

MeasureTime frame
Sedation Orientation Amnesia Cognitive and psychomotor dysfunction Timepoint: baseline status checked, that is before drug administration and rechecked one hour after drug administration

Secondary

MeasureTime frame
� Anxiolysis � Adverse effects such as nausea, vomiting, hemodynamic disturbances etc Timepoint: baseline status checked, that is before drug administration and rechecked one hour after drug administration

Countries

India

Contacts

Public ContactDrSSreeRanjini

Bhaarath medical college hospital

anaesthesiology@bmch.ac.in9840770817

Outcome results

None listed

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