| CTRI Number |
CTRI/2022/05/042885 [Registered on: 27/05/2022] Trial Registered Prospectively |
| Last Modified On: |
21/05/2022 |
| 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
|
A Study to compare the effect of three drugs -Dexmedetomidine, Lidocaine and Fentanyl in increasing heart rate and blood pressure in response to Laryngoscopy and Intubation in patients undergoing Cardiac Surgery |
|
Scientific Title of Study
|
A prospective, randomized, double blinded, controlled study for comparison of Dexmedetomidine, Lidocaine and Fentanyl in attenuation of Hemodynamic response to Laryngoscopy and Intubation in patients undergoing Cardiac Surgery at SMS Medical College, Jaipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
S.M.S Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Building, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
S.M.S Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Building, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthik K |
| Designation |
Junior Resident |
| Affiliation |
S.M.S Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Building, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9980194668 |
| Fax |
|
| Email |
karthik.kateel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, S.M.S Medical College, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan, 302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology, S.M.S Medical College, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004 |
| 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 Indu Verma |
S.M.S Medical College Hospital |
Cardiac Surgery Operation Theatre, 2nd Floor, Bangad Parisar Building, Department of Anaesthesia, S.M.S Hospital, Jaipur
Jaipur
RAJASTHAN |
9413622967
dr.induverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee,S.M.S Medical College and Attached Hospitals, Jaipur |
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 |
| Intervention |
Intravenous Dexmedetomidine |
1 microgram/kg of Intravenous Dexmedetomidine for 10 minutes before laryngoscopy |
| Intervention |
Intravenous Fentanyl |
2 microgram/kg of Intravenous Fentanyl 90 seconds before intubation |
| Comparator Agent |
Intravenous Lidocaine |
1.5 milligram/kg of Intravenous Lidocaine 90 seconds before intubation |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Informed Consent
2.Patients undergoing Elective Cardiac Surgery
3.Ejection Fraction >35%
4.ASA Grade 2 and 3
5.BMI<30 |
|
| ExclusionCriteria |
| Details |
1.Intubation Attempt lasting longer than 15s and any intubation related problem
2.Allergic Sensitivity to the research medications
3.Patients with hypotension(SBP<90 mmhg)
4.Bradycardia(HR<60/min)
5.Diabetes
6.Asthma
7.Pregnancy
8.Chronic Kidney and liver diseases
9.Long QT
10.Any Addiction |
|
|
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 |
| Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure |
Before Intubation and 1,3,5,10 and 15 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of cases who experience side effects or complications(if any) |
24 hours postoperation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/06/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and endotracheal intubation are associated with various hemodynamic changes due to sympathetic stimulation and to attenuate these responses is a major challenge for the anaesthesiologist. Hence, this study is designed to compare effects of intravenous Dexmedetomidine, Lidocaine and Fentanyl in Attenuation of Hemodynamic Response of Laryngoscopy and Intubation in patients undergoing Cardiac surgery. |