| CTRI Number |
CTRI/2024/11/076286 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of oral midazolam and pregabalin |
|
Scientific Title of Study
|
Comparison of Effect of Oral Midazolam and Pregabalin as Premedicants on Hemodynamic Response During General Anaesthesia in Elective Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jananipriya T R |
| Designation |
PG student |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Sri Devaraj Urs Medical College, room no. 111,PG ladies hostel,Department of Anaesthesia,Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9790678706 |
| Fax |
|
| Email |
jananipriya1224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRavi Madhusudhana |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Anaesthesiology, Sri Devaraj Urs Medical College ,Tamaka ,Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9845287591 |
| Fax |
|
| Email |
ravijaggu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRavi Madhusudhana |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Anaesthesiology, Sri Devaraj Urs Medical College ,Tamaka ,Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9845287591 |
| Fax |
|
| Email |
ravijaggu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical college, Tamaka, Kolar,karnataka-563101, India |
|
|
Primary Sponsor
|
| Name |
Jananipriya T R |
| Address |
Sri Devaraj Urs Medical College, Tamaka, Kolar,karnataka-563101,India |
| 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 |
| Jananipriya T R |
Sri Devaraj urs medical college |
Room no.111,Department of anaesthesia, tamaka, kolar-563101
Kolar
KARNATAKA |
9790678706
jananipriya1224@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| central ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Midazolam
dose-7.5mg
oral route
intraoperative and post operative period within 1 hour |
To look for hemodynamic response during General Anaesthesia |
| Comparator Agent |
Pregabalin
dose-150mg
orally
intra operatively and post operatively within 1 hour |
To look for hemodynamic response during General Anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2
Elective surgeries under general anaesthesia
Duration of surgery:60 to 180 minutes |
|
| ExclusionCriteria |
| Details |
Pre-existing co-morbidities
Anticipated difficult intubation
Epileptics
Pregnant patients
Patients on antidepressants |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of pregabalin and midazolam in attenuating hemodynamic response during surgery under general anaesthesia |
60 to 180 minutes intraoperatively
2 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the pain score |
60 to 180 minutes intraoperatively
2 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
11/11/2024 |
| 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
|
Oral Midazolam was given to one group and oral Pregabalin was given to other group 2 hours prior to surgery.Hemodynamic response will be assessed during surgeryand 2hrs postoperatively. This shows which drug has more efficacy towards hemodynamic response. |