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Comparison of effect of two drugs on nervousness before operation in adult patients

Impact of oral melatonin versus alprazolam on preoperative anxiety in adult patients posted for elective surgery under general anaesthesia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057795
Enrollment
80
Registered
2023-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Interventions

Intervention1: alprazolam: tablet alprazolam 0.5 mg per oral will be given to patients 60 minutes prior to induction of anaesthesia Control Intervention1: Melatonin: Tablet melatonin 5 mg per oral wil

Sponsors

Guru Gobind Singh Medical College and Hospital Faridkot
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients of ASA I and II posted for elective surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. obese patients with BMI >30, thyroid disorders or any other psychiatric illness 2. patients diagnosed with sleep disorders and drug abusers 3. patients on medications like beta blockers, sedatives, antipsychotics and antiepileptics 4. patients with visual impairment 5. patients unable to read or write basic alphabets 6. those with history of allergy to study drugs 7. pregnant and lactating females

Design outcomes

Primary

MeasureTime frame
anxietyTimepoint: 10 minutes before drug administration, 15, 30,60 minutes after drug administration, before shifting patint to operation theater, just before shifting patient from PACU to ward

Secondary

MeasureTime frame
cognitive functionTimepoint: 10 minutes before and 15,30 ,60 minutes after drug administration, before shifting to ot, before shifting from PACU to ward, 24 hours after drug administration (next day);orientationTimepoint: 10 minutes before and 15,30, 60 minutes after drug administration, before shifting to ot, before shifting from PACU to ward;psychomotor functionTimepoint: 10 minutes before and 24 hours after drug administration

Countries

India

Contacts

Public ContactDr Yadvinder Singh Sidhu

Baba Farid university of Health Sciences Faridkot

jindalseema77@gmail.com9646050485

Outcome results

None listed

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