| CTRI Number |
CTRI/2025/09/094284 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Pregabalin and Gabapentin for reduction of preoperative anxiety |
|
Scientific Title of Study
|
Comparison of Pregabalin and Gabapentin for preoperative anxiolysis: A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNandhinimurugesan |
| Designation |
DNB Anaesthesiology Resident |
| Affiliation |
Dr.Rangarajan Memorial Hospital, |
| Address |
,Dr.Rangarajan Memorial Hospital,
Sundaram Medical foundation,
1st floor,Department of Anaesthesiology,
4th a venue,Anna nagar,Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
9976982196 |
| Fax |
|
| Email |
drnandhinimurugesan19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Lynda Franklin |
| Designation |
HOD of Department of anaesthesiology |
| Affiliation |
Dr.Rangarajan Memorial Hospital, |
| Address |
1st floor,Operation theatre,Department of Anaesthesiologo,Sundaram Medical foundation,Dr.Rangarajan Memorial Hospital,4th avenue,Anna nagar,Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
9976982196 |
| Fax |
|
| Email |
Lyndaprem@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNandhinimurugesan |
| Designation |
DNB Anaesthesiology Resident |
| Affiliation |
Dr.Rangarajan Memorial Hospital, |
| Address |
1st floor,Operation theatre,Department of Anaesthesiologo,Sundaram Medical foundation,Dr.Rangarajan Memorial Hospital,4th avenue,Anna nagar,Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
9976982196 |
| Fax |
|
| Email |
drnandhinimurugesan19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Rangarajan memorial hospital,Sundaram medical foundation,4th avenue,Shanthi colony,Annna nagar,Chennai 600040 |
|
|
Primary Sponsor
|
| Name |
DrNandhinimurugesan |
| Address |
Ap33, 5th street,L block,Krimji colony,Anna nagar,Chennai 600040 |
| Type of Sponsor |
Other [This is post graduate thesis study] |
|
|
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 |
| DrNandhini |
Dr.Rangarajan memorial hospital |
1st floor,Operation theatre, Department of Anaesthesiology,4th avenue,Shanthi colony,Anna nagar
Chennai 600040
Chennai
TAMIL NADU |
9976982196
drnandhinimurugesan19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sundaram Medical Foundation,Dr.Rangarajan Memorial Hospital |
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 |
Gabapentin |
Patients enrolled with groupG will receive Gabapentin 600mg one or two hours before surgery.Principal investigator and Patients will be blinded to the test group |
| Intervention |
PREGABALIN |
Patients enrolled with group P will receive PREGABALIN 150mg one or two hours before surgery.Principal investigator and Patients will be blinded to the test group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults ASA I/II/III
Above 18 years
Elective procedures
All types of anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patient who does not give consent to the study
Patients with anxiety score of 0
Allergy to pregabalin and gabapentin
Abnormal liver/ renal function
K/c/o cognitive and neurological disorder
Pregnancy/breast feeding.
H/o drug / alcohol abuse
Patient on regular medication with pregabalin/gabapentin
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the reduction in preoperative anxiety between two drugs
|
6months-1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the sedation score and side effects between two drugs
|
6months-1year |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
This is double blind randomised controlled trial to compare pregabalin and Gabapentin for preoperative anxiolysis.Primary outcome of study will be to assess the reduction in preoperative anxiety between two drugs.Secondary outcomes will be to assess the sedation score and side effects between two drugs |