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A study of two drugs melatonin and diazepam given orally to compare anxiety and sedation experienced by the patients in preoperative period before undergoing general anesthesia.

Oral Melatonin and Oral Diazepam - A comparative study for anxiety and sedation in patients under general anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035156
Enrollment
80
Registered
2021-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 5mg versus Oral Diazepam 5mg, given 2 hours before general anaesthesia: A. To study the effect and efficacy on pre operative anxiety and sedation at 15,30,60 and 90 minut

Sponsors

Dr Swastika Aggarwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status 1 and 2 of either sex scheduled for surgeries under general anesthesia

Exclusion criteria

Exclusion criteria: Patients with sleep disorders. Pregnant and lactating females. Patients with history of psychiatric disorders or any anti psychotic drugs. Patients with severe renal or hepatic derangements. Hypersensitivity to melatonin or diazepam. Patients taking opioids, benzodiazepines, drug or alcohol abuse.

Design outcomes

Primary

MeasureTime frame
Comparing the effects of Oral melatonin and oral diazepam on anxiety and sedationTimepoint: Before giving the study drug, 15,30 ,60 and 90 minutes after giving the study drug 15,30,60 and 90 minutes after the surgery to compare anxiety and sedation—

Secondary

MeasureTime frame
nilTimepoint: nil—

Countries

India

Contacts

Public ContactDr Narendra Babu MC

Kempegowda institute of medical sciences, Bangalore

narendrababuchanappa@gmail.com9900214064

Outcome results

None listed

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