| CTRI Number |
CTRI/2024/03/064856 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparing effect of giving two oral tablets before surgery on decreasing stress during general anaesthesia |
|
Scientific Title of Study
|
Comparing the effects of oral clonidine and oral pregabalin on pre operative anxiolysis and stress response to laryngoscopy and intubation in patients undergoing elective surgery under general anaesthesia a prospective randomised double blind study |
| 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 B Arun Kumar |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Arun Kumar |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem Kumar |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15, Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
7730017117 |
| Fax |
|
| Email |
princeprem.kumar7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Chinnaseeragapadi Salem |
| Type of Sponsor |
Private 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 V Prem Kumar |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU |
7730017117
princeprem.kumar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
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 |
Clonidine |
Administration of single stat dose of oral clonidine 0.3 mg 90 minutes prior to surgery |
| Intervention |
Comparing between two drugs one alpha 2 agonist and another anti convulsant |
Comparing the effects of oral clonidine and oral
pregabalin on pre operative anxiolysis and stress response to laryngoscopy &
intubation in patients undergoing elective surgery under general anaesthesia
a prospective randomised double blind study |
| Comparator Agent |
Pregabalin |
Administration of single stat dose of oral pregabalin 150 mg 90 minutes prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and 2
2. Age between 20-60 years
3. Mallampati grade 1 and 2
4. Elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Age more than 60 years and less than 20 years
2.ASA grade 3 & 4
3.Patient refusal
4.Anticipated difficult intubation
5.Allergic to clonidine and pregabalin
6.Pregnant and breast feeding patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clonidine is more effective than pregabalin in lowering the blood pressure and heart rate changes |
30 minutes after drug administration upto 10 minutes post induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pregabalin has more sedation and less bradycardia as compared to clonidine |
30 minutes after drug administration upto 10 minutes post induction |
|
|
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)
|
05/04/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - -
- For how long will this data be available start date provided 18-03-2024 and end date provided 18-03-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Comparing the effects of oral clonidine and oral pregabalin on pre operative anxiolysis and stress response to laryngoscopy and intubation in patients undergoing elective surgery under general anaesthesia - A prospective randomised double blind study. Comparing the sedative and hemodynamic parameters (heart rate, blood pressure, mean arterial pressure and oxygen saturation) between oral clonidine and oral pregabalin. |