| CTRI Number |
CTRI/2025/01/079825 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Comparison of Zopiclone, Melatonin, and Alprazolam as a pre-medication on preoperative anxiety, psychomotor functions, and soporific effect |
|
Scientific Title of Study
|
Premedication before surgeries: A Comparison of Zopiclone, Melatonin, and Alprazolam on preoperative anxiety, psychomotor functions, and soporific effect. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atul Aman |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
9088955257 |
| Fax |
|
| Email |
dratulaman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atul Aman |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
WEST BENGAL
741245
India |
| Phone |
9088955257 |
| Fax |
|
| Email |
dratulaman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atul Aman |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
WEST BENGAL
741245
India |
| Phone |
9088955257 |
| Fax |
|
| Email |
dratulaman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund of AIIMS Kalyani, Basantapur, NH-34 connector, Dist. Nadia, West bengal , India. pin -741245 |
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Aman |
AIIMS Kalyani OT Complex |
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL |
9088955257
dratulaman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Kalyani |
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 |
| Comparator Agent |
Alprazolam |
Group A: Patients will receive a tablet of alprazolam 0.5 mg at 10 pm on the night before surgery as a pre-medication only once.
|
| Intervention |
Melatonin |
Group C: Patients will receive a melatonin tablet of 10 mg likewise only once |
| Comparator Agent |
Zopiclone |
Group B:Patients will receive a tablet of 7.5 mg of zopiclone similarly as pre medication only once |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II, Patients undergoing major elective surgeries of duration less than three hours. |
|
| ExclusionCriteria |
| Details |
1. Surgery duration of more than three hours,
2. Myasthenia gravis,
3. Chronic intake of psychotropic drugs,
4. Patients habitually taking hypnotics,
5. Severe obestructive sleep apnea,
6. Intracranial hypertension,
7. Morbid obesity,
8. Pregnant patients,
9. Patients unable to read or write basic alphabets, and
10. Re-do surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the change of VAS-A score in melatonin, zopiclone, and alprazolam group on preoperative anxiety. |
on the night before surgery before giving the drug ,
and on the morning of surgery at 8:00 AM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the change of Digital Symbol Substitution Test in the melatonin, zopiclone, & alprazolam groups on preoperative & postoperative psychomotor functions. |
in the morning before surgery at 8:00 am & five hours after the end of surgery. |
| compare the change of the four-point sedation scale between the melatonin, zopiclone, & alprazolam groups. |
in the morning of surgery at 8:00 AM |
| To compare the level of sedation in patients receiving melatonin, zopiclone, & alprazolam. |
on the morning of surgery |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="0"
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
|
It is a Prospective, double-blind, randomized, comparative study.This study will be conducted to evaluate and compare the effect of melatonin, zopiclone, and alprazolam on preoperative anxiety, sedation, and psychomotor function in major elective surgeries |