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

Phase 3

Not yet recruiting

Brief Summary: The study will be conducted in a comparative manner in the Department of Anaesthesiology GGS medical college & Hospital Faridkot on 100 adult pts of age between 20-60 years of either gender ASA1and II scheduled to undergo elective surgery under G.A.The pts will be allocated into 2 groups of 50 pts each. Group M pts will receive Tab Melatonin 5mg per oral. Group A pts will receive Tab Alprazolam 0.5 mg per oral. Baseline heart rate, SPo2, B.P.(systolic, diastolic, mean arterial pressure), scores of anxiety, sedation, orientation and DSST will be assesssed 15 min before drug administration. These parameters except DSST and memory recall scores will then be assesssed after 15,30 min of drug administration, before shifting pt to ot and just before shifting the pt from PACU to ward. DSST and memory recall score will be assesssed 24 hrs after surgery. Anxiety and sedation will be assessed by Ramsay sedation score, RAAS and the orientation will be assessed by 3 point orientation score. The cognitive function will be assesssed by showing different pictures to pt and the score will be done based on no. of pictures correctly recalled or recognized by them after 24 hours. The psychomotor function will be assessed by DSST score.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
patient s anxiety by using anxiety score	15 minutes before and 15, 30 minutes after drug administration, befre shifting to ot, just before shifting from PACU to ward

Secondary Outcome Measures

Name	Time	Method
1. patient s sedation level using sedation score	2. orientation of patient using 3 point orientation score

Locations (2): Guru Gobind Singh Medical college and hospital Faridkot
🇮🇳
Faridkot, PUNJAB, India
Department of Anaesthesiology main operation theater complex second floor
🇮🇳
Faridkot, PUNJAB, India
Guru Gobind Singh Medical college and hospital Faridkot
🇮🇳Faridkot, PUNJAB, India
Seema Jindal
Principal investigator
09646050485
jindalseema@ggsmch.org