| CTRI Number |
CTRI/2025/04/085231 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of effect of two tablets melatonin and alprazolam given by mouth on anxiety in adult patients posted for surgery |
|
Scientific Title of Study
|
A comparative study of impact of oral melatonin versus alprazolam on anxiety in adult patients undergoing elective surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Jindal |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, GGS medical college and hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9646050485 |
| Fax |
|
| Email |
jindalseema@ggsmch.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Jindal |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, GGS medical college and hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9646050485 |
| Fax |
|
| Email |
jindalseema@ggsmch.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palash Kumar Verma |
| Designation |
Post graduate student |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, GGS medical college and hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8899262445 |
| Fax |
|
| Email |
vermapalash7285@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
GGS Medical College and Hospital Faridkot punjab, india
pin code 151203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Seema Jindal |
Guru Gobind Singh Medical college and hospital Faridkot |
Department of Anaesthesiology, main operation theater complex, second floor, GGS Medical college and hospital
Faridkot
PUNJAB |
09646050485
jindalseema@ggsmch.org |
| Dr Palash Kumar Verma |
Department of Anaesthesiology main operation theater complex second floor |
GGS Medical college and Hospital
Faridkot
PUNJAB |
08899262445
vermapalash7285@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee Guru Gobind Singh Medical college and hospital Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
alprazolam |
impact of alprazolam on anxiety in adult patients undergoing elective surgery |
| Comparator Agent |
Tablet Melatonin 5 mg per oral 60 minutes prior to induction with sip of water |
impact of melatonin in adult patients undergoing elective surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
100 patients of either gender ASA 1 and II scheduled to undergo elective surgery under G.A. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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 function |
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 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |