| CTRI Number |
CTRI/2020/06/026033 [Registered on: 22/06/2020] Trial Registered Prospectively |
| Last Modified On: |
15/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of drug esmolol and clonidine for suppression in heart rate and blood pressure after endotracheal tube placement. |
|
Scientific Title of Study
|
A comparative study of intravenous clonidine versus esmolol for attenuation of hemodynamic response associated with laryngoscopy and intubation in abdominal surgeries under general anaesthesia: A randomised double blind interventional study at sms hospital jaipur during year 2109-20 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr sunil chauhan |
| Designation |
Senior professor |
| Affiliation |
Sms medical college |
| Address |
Department of anaesthiology,
Sms medical college, jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
Suncha87@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sunil chauhan |
| Designation |
Senior professor |
| Affiliation |
Sms medical college |
| Address |
Department of anaesthiology,
Sms medical college, jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
Suncha87@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr satyaprakash |
| Designation |
Pg student |
| Affiliation |
Sms medical college, jaipur |
| Address |
Department of anaesthiology,
Sms medical college, jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9694213286 |
| Fax |
|
| Email |
docsp1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, sms medical college, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology sms medical college |
| Address |
Department of anaesthiology,
Sms medical college, jaipur
Rajasthan |
| Type of Sponsor |
Government 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 sunil chauhan |
Sms medical college, jaipur |
Room no. B-84, resident doctor hostel.
Department of anaesthiology.
Jaipur
RAJASTHAN |
9414077324
Suncha87@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, sms medical college, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Attenuation of hemodynamic response after laryngoscopy and intubation by drug esmolol or clonidine |
Comparative study of intravenous clonidine versus esmolol for attenuation of hemodynamic response associated with laryngoscopy and Intubation in abdominal surgeries under general anaesthesia |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 & A2
Elective abdominal surgeries |
|
| ExclusionCriteria |
| Details |
1-Unwilling to participate in study
2-patient with difficult airway
3-patient known allergic to test drug
4-history of medication affecting heart rate and blood pressure
5-heart rate less than 60
6-bleeding disorder |
|
|
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 |
1-Mean heart rate
2-Mean systolic blood pressure
3-Mean diastolic blood pressure
4-Mean arterial blood pressure
|
Hemodynamic variables at
1- base line
2-before study drug
3-after study drug
4-before incubation
5- 1minute 3 minute 5 minute and 10 minute post Intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects |
post operative side effects
At 1hour 6hour 12 hour and 24 hour |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
25/06/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we aim to compare the efficacy of intravenous clonidine (1 micro gram/kg body weight) versus intravenous esmolol (1mg/kg body weight) for attenuation of hemodynamic response associated with laryngoscopy and Intubation in abdominal surgeries under general anaesthesia. |