| CTRI Number |
CTRI/2019/12/022550 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hemodynamic stability during laryngoscopy and intubation with the use of Dexmedetomidine in severe mitral stenosis patients, posted for mitral valve replacement. |
|
Scientific Title of Study
|
Use of Dexmedetomidine in attenuating the stress response to laryngoscopy and and intubation in patients undergoing mitral valve replacement for severe mitral stenosis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Sharma |
| Designation |
PG student |
| Affiliation |
Delhi University |
| Address |
Department of Anesthesia
A block, sixth floor
GB Pant Hospital
Department of CTVS
C block, second floor
GB Pant hospital
Central
DELHI
110002
India |
| Phone |
7018546368 |
| Fax |
|
| Email |
shvaroon09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjula Virmani |
| Designation |
Professor |
| Affiliation |
Delhi University |
| Address |
Department of Anesthesia
A block, sixth floor
GB Pant Hospital
Department of CTVS
C block, second floor
GB Pant Hospital
Central
DELHI
110002
India |
| Phone |
9718599409 |
| Fax |
|
| Email |
drsanjulavirmani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Varun Sharma |
| Designation |
PG student |
| Affiliation |
GB Pant |
| Address |
Department of Anesthesia
A block, sixth floor
GB Pant Hospital
Department of CTVS
C block, second floor
GB Pant Hospital
Central
DELHI
110002
India |
| Phone |
7018546368 |
| Fax |
|
| Email |
shvaroon09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GB Pant Hospital |
| Address |
JLN Marg, New Delhi - 110002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Varun Sharma |
GB Pant Hospital |
B Block, Second Floor, CTVS operation theatre.
Central
DELHI |
7018546368
shvaroon09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I050||Rheumatic mitral stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug Dexmedetomidine |
A single dose of 0.5mcg/kg will be diluted in 100 ml volume and infused over 10 minutes using infusion pump after securing intravenous access.Following standard induction,hemodynamics will be noted down immediately before laryngoscopy and at 1,3,5 and 10 minutes post intubation. |
| Comparator Agent |
Drug Thiopentone (Control Group) |
A single bolus of 2mg/kg will be administered during standard induction and hemodynamics will be noted down before laryngoscopy and 1,3,5 and 10 minutes post intubation.Outcome will be compoared to intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
undergoing mitral valve replacement for severe mitral stenosis (Mitral valve area < 1cm2) with or without associated mitral regurgitation. |
|
| ExclusionCriteria |
| Details |
Associated other valvular lesions
Coexisting hepatic, renal or severe respiratory dysfunction
Coexisting coronary artery disease
Ejection fraction < 45%
Obesity (BMI> 30)
Severe systemic disorder (uncontrolled hypertension, insulin dependent DM)
Conduction abnormalities - AV block
Preoperative use of alpha 2 receptor agonists
Intubation attempts lasting > 20 sec
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Haemodynamic response at 1,3,5 and 10 minutes after endotracheal intubation.
|
1) 1,3,5 and 10 minutes after endotracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesic consumption during surgery and any other adverse effect of drug |
Throughout procedure(beginning till end) |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
30/12/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
https://doi.org/10.1053/j.jvca.2019.06.014 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dexmedetomidine, an alpha 2 receptor agonist has the ability to blunt the response to any noxious stimuli providing hemodynamic instability. Literature regarding its use in patients with mitral stenosis with the aim to control the heart rate is scarce, hence we aimed to use dexmedetomidine as an adjunct to anesthetic induction and to study the effect of intravenous bolus of dexmedetomidine on heart rate and blood pressure during induction of anesthesia in patients with severe MS undergoing mitral valve replacement. Objectives of the study are 1) To compare the effect of fentanyl and dexmedetomidine anesthetic induction with fentanyl and thiopentone induction technique on heart rate and blood pressure in such patients 2) To compare cumulative analgesic requirement during surgery and other adverse effects of drug |