| CTRI Number |
CTRI/2024/09/074438 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing Oral Melatonin and Pregabalin for Reducing Anxiety and Postoperative Pain in Daycare Surgeries |
|
Scientific Title of Study
|
Comparative Evaluation of oral Melatonin and Pregabalin as premedicants for perioperative anxiety and post operative pain in daycare surgeries-A Randomized control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reeya Mathew |
| Designation |
Postgraduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, SBV Chennai Campus, Shri Sathya Sai Nagar, Ammapettai, Chengalpet
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7380313783 |
| Fax |
|
| Email |
reeyamathewmsj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Prasad |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical college and Research institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, SBV Chennai Campus, Shri Sathya Sai Nagar, Ammapettai, Chengalpet
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Prasad |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical college and Research institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, SBV Chennai Campus, Shri Sathya Sai Nagar, Ammapettai, Chengalpet
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Reeya Mathew, Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, SBV Chennai Campus, Shri Sathya Sai Nagar, Ammapettai, Chengalpet |
|
|
Primary Sponsor
|
| Name |
Reeya Mathew |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, SBV Chennai Campus, Shri Sathya Sai Nagar, Ammapettai, Chengalpet |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Reeya Mathew |
Shri Sathya Sai Medical College and Research Institute |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, SBV Chennai Campus, Shri Sathya Sai Nagar, Ammapettai, Chengalpet
Kancheepuram
TAMIL NADU |
7380313783
reeyamathewmsj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Sathya Sai Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z764||Other boarder to healthcare facility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab. Melatonin (Group X) |
Tab. Melatonin 3mg will be given to patients 6 hours prior surgery |
| Comparator Agent |
Tab. Pregabalin(Group Y) |
Tab. Pregabalin 75mg will be given to patients 6 hours prior surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 years to 60 years
2. Patients undergoing daycare surgeries
3. Both Sex
4. ASA I-III |
|
| ExclusionCriteria |
| Details |
1. Not willing
2. Patient on long term analgesics and opioid containing drugs
3. Allergy to those medications
4. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check for effective analgesia between study groups using Visual Analogue Score(VAS) |
baseline, 4th hour, 8th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate anxiety relieving effect and sedation between two groups using Beck Anxiety Inventory Scale and Observer Assessment Alertness Scale |
baseline, 4th hour, 8th hour |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/10/2024 |
| 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 Applicable |
| 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
|
After getting approval from ethical committee, Patients posted for daycare surgeries will be taken up for study after obtaining written and informed consent. Pre-anaesthetic checkup will be done and those patients who fit into the inclusion criteria will be analyzed thoroughly and taken up for the study. Patients will be randomized into two groups, the Melatonin group and the Pregabalin group. Melatonin group patients will receive 3mg of Tab. Melatonin 6 hours before surgery. The other group will be given Tab. Pregabalin 75mg 6 hours before surgery. Patient will be kept NPO 8 hours before surgery. VAS, Anxiety Score and Sedation score will be noted at the time intervals from the beginning of premedication 4th hourly. |