A comparative study of effect of two tablets melatonin and alprazolam given by mouth on anxiety in adult patients posted for surgery

A comparative study of impact of oral melatonin versus alprazolam on anxiety in adult patients undergoing elective surgery - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085231

Enrollment

100

Registered

2025-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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: impact of alprazolam on anxiety in adult patients undergoing elective surgery Control Intervention1: Tablet Melatonin 5 mg per oral 60 minutes prior to induction with sip of

Eligibility

Inclusion criteria

Inclusion criteria: 100 patients of either gender ASA 1 and II scheduled to undergo elective surgery under G.A.

Exclusion criteria

Exclusion criteria: 1. patients with any neuropsychiatric illness 2. pts diagnosed with sleep disorders and drug abuse 3. pts on medications like beta blockerssedatives, antipsychotics, anxiolytics, antiepileptics and antidepressants 4. pts with visual impairment 5.pts with inability to read and write basic alphabets 6.history of allergy to study drugs 7. pregnanat and lactating females

Design outcomes

Primary

Measure	Time frame
patient s anxiety by using anxiety scoreTimepoint: 15 minutes before and 15, 30 minutes after drug administration, befre shifting to ot, just before shifting from PACU to ward	—

Secondary

Measure	Time frame
1. patient s sedation level using sedation score 2. orientation of patient using 3 point orientation score 3. DSST(Digital Symbol Substituition Test) for assessing psychomotor functionTimepoint: 1. baseline, 15,30 minutes after drug administration, before shifting to ot,just before shifting from PACU to ward 2.Baseline, 15, 30 minutes after drug administration, before shifting to ot, just before shifting from PACU to ward 3.baseline, 24 hrs after surgery	—

Measure

Time frame

1. patient s sedation level using sedation score 2. orientation of patient using 3 point orientation score 3. DSST(Digital Symbol Substituition Test) for assessing psychomotor functionTimepoint: 1. baseline, 15,30 minutes after drug administration, before shifting to ot,just before shifting from PACU to ward 2.Baseline, 15, 30 minutes after drug administration, before shifting to ot, just before shifting from PACU to ward 3.baseline, 24 hrs after surgery

—

Countries

India

Contacts

Public ContactDr Palash Kumar Verma

Guru Gobind Singh Medical College and Hospital

jindalseema@ggsmch.org9646050485

Outcome results

None listed

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