| CTRI Number |
CTRI/2025/03/082299 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of tab clonidine with tab pregabalin for decreasing of stress response to laryngoscopy and intubation in patients posted for elective general anaesthesia |
|
Scientific Title of Study
|
Comparision of oral clonidine with oral pregabalin in attenuation of the pressor response to direct laryngoscopy and tracheal intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshini Shashidharan |
| Designation |
Post graduate |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
First floor, New stone building, Department of anaesthesiology, Mysore Medical College and Research Institute, Irwin road, next to railway station, Mysore.
First floor, New stone building, Department of anaesthesiology, Mysore Medical College and Research Institute, Irwin road, next to railway station, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
7204499021 |
| Fax |
|
| Email |
darshinishashidharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sudarshan M B |
| Designation |
Associate professor |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
1st floor,New stone building, Department of anaesthesiology, Mysore Medical College and Research Institute, Irwin road, next to railway station, Mysore.
1st floor,New stone building, Department of anaesthesiology, Mysore Medical College and Research Institute, Irwin road, next to railway station, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
9900262710 |
| Fax |
|
| Email |
drmbs1975@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Sudarshan M B |
| Designation |
Associate professor |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
1st floor, New Stone Building Department of anaesthesiology, Mysore Medical College and Research Institute, Irwin road, next to railway station, Mysore.
1st floor, New Stone Building Department of anaesthesiology, Mysore Medical College and Research Institute, Irwin road, next to railway station, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
9900262710 |
| Fax |
|
| Email |
drmbs1975@yahoo.com |
|
|
Source of Monetary or Material Support
|
| mysore medical college and research institute, irwin road, mysore karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Darshini Shashidharan |
| Address |
Mysore Medical College and Research Institute, Irwin road, next to railway station, Mysore. |
| 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 |
| Dr DARSHINI SHASHIDHARAN |
Mysore Medical College and Research Institute |
Operation Theatre, Department of Anaesthesiology, first floor, New Stone Building, KR hospital.
Mysore
KARNATAKA |
7204499021
darshinishashidharan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, Mysore Medical College and Research Institute and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
compariosion between oral clonidine 200mcg and oral pregabalin 150 mg in attenuation of intubation response |
comparing effects of oral clonidine 200mcg and oral pregabalin 150 mg given 90 mins prior to intubation in attenuation of stress response in patients undergoing general anesthesia posted for elective surgeries. patient is observed for a period of 15 mins |
| Intervention |
two drugs, oral clonidine 200 mcg and oral pregabalin used prior to laryngoscopy and intubation |
two drugs, oral clonidine 200 mcg and oral pregabalin used prior to laryngoscopy and intubation to know its effects for about 15 minutes post intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all ASA grade 1 and 2 patients between 18 to 65 years age group. |
|
| ExclusionCriteria |
| Details |
1)ASA grade 3 and 4
2) patients with diabetes and hypertension
3) patients who have drug allergy
4) pregnant and lactating women
5) patients with chronic respiratory and cardiovascular disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study and compare the effects of oral clonidine 200 mcg with oral pregabalin 150 mg on hemodynamic response to laryngoscopy and endotracheal intubation |
From shifting on ot table till 15 mins post endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) to evaluate any side effects with use of this drugs.
2)seadtion and anxiety scores |
90 mins prior intubation to 15 mins after intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="3"
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 a prospective randomised controlled study to compare the effects of oral clonidine 200 mcg with oral pregabalin 150 mg in attenuation of response to laryngoscopy and endotracheal intubation. sample size is 80. patients posted for elective surgeries under general anaesthesia are randomly divided into two groups, 40 receiving oral clonidine 200mcg and 40 receiving oral pregabalin 150 mg prior to intubation. hemodynamic response are recorded in those patients and effects are compared. |