| CTRI Number |
CTRI/2022/06/043086 [Registered on: 08/06/2022] Trial Registered Prospectively |
| Last Modified On: |
13/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Checking the effect of nebulised dexmedetomidine on pulmonary blood pressure in cardiac surgeries |
|
Scientific Title of Study
|
The effect of pre-operative dexmedetomidine nebulisation on pulmonary haemodynamics during laryngoscopy and intubation in cardiac surgery patients: A prospective randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhdeep Singh |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology AIIMS Rishikesh Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
deep494950@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Additional professor |
| Affiliation |
All India Institute Of Medical Sciences , Rishikesh |
| Address |
Department of Anaesthesiology AIIMS Rishikesh Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
ajaymishra0701@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Additional professor |
| Affiliation |
All India Institute Of Medical Sciences , Rishikesh |
| Address |
Department of Anaesthesiology AIIMS Rishikesh Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
ajaymishra0701@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology AIIMS, Rishikesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Shubhdeep Singh |
AIIMS Rishikesh |
Major OT complex
Level 6 AIIMS
Rishikesh Virbhadra
Road
Dehradun
UTTARANCHAL |
9463123119
deep494950@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I258||Other forms of chronic ischemic heart disease, (2) ICD-10 Condition: I050||Rheumatic mitral stenosis, (3) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (4) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency, (5) ICD-10 Condition: I058||Other rheumatic mitral valve diseases, (6) ICD-10 Condition: I070||Rheumatic tricuspid stenosis, (7) ICD-10 Condition: I071||Rheumatic tricuspid insufficiency, (8) ICD-10 Condition: I072||Rheumatic tricuspid stenosis and insufficiency, (9) ICD-10 Condition: I078||Other rheumatic tricuspid valve diseases, (10) ICD-10 Condition: I081||Rheumatic disorders of both mitraland tricuspid valves, (11) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine |
Nebulisation in pre-operative period @ 1mcg/kg body weight diluted to 3ml, stat, for 10 mins duration |
| Comparator Agent |
Normal saline |
Nebulisation with 3 ml normal saline in pre-operative period , stat, for 10 mins duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1. Age 18-55 years
2. Both genders
3. Elective cardiac surgery
4. Mitral valve repair or replacement
5. Mitral stenosis, mitral regurgitation
6. Coronary artery bypass graft with mitral valve replacement |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1. Anticipated difficult airway.
2. Preoperative heart rate < 50 bpm
3. Uncontrolled AF and ventricular rate
4. Second degree heart block and bundle branch blocks
5. Patients with both mitral and aortic valve disease
6. Right atrial mass or thrombus
7. Emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare change in pulmonary artery systolic pressure (PASP) and mean pulmonary artery pressures (mPAP) during laryngoscopy and intubation. |
Within 2 successful intubation attempts |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare change in pulmonary vascular resistance (PVR)during laryngoscopes and intubation |
every 1 minute of induction of anesthesia till 15 minutes following intubation |
| Compare PASP and systolic blood pressure (SBP) ratio (PASP/SBP) during laryngoscopy and intubation |
every 1 minute of induction of anesthesia till 15 minutes following intubation |
| Compare PASP, PADP, mPAP, PVR, SBP, DBP, MAP, systemic vascular resistance, cardiac output (CO) and cardiac index (CI) |
every 1 minute of induction of anesthesia till 15 minutes following intubation |
| Compare dose of propofol and fentanyl required during intubation response to optimise blood pressure |
every 1 minute of induction of anesthesia till 15 minutes following intubation |
| Compare dose of inotropes or vasopressors required |
every 1 minute of induction of anesthesia till 15 minutes following intubation |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
10/06/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and intubation both produce stress response by increasing heart rate, blood pressure, pulmonary artery pressures.
The effect of dexmedetomidine to reduce systemic haemodynamic response during laryngoscopy and intubation is demonstrated in cardiac and non cardiac patients.
Inhalational route has been found to have less systemic effects such as hypotension and bradycardia than intravenous route.
Whether the reduction in pulmonary haemodynamic response during induction is significant or not has not been studied much.
Hypotheses is nebulised dexmedetomidine is more effective in preventing increase in pulmonary artery pressures compared to placebo during laryngoscopy and intubation in cardiac surgery patients.
Primary objective is to compare change in pulmonary artery pressure parameters (pulmonary artery systolic pressure and mean pulmonary artery pressures) during laryngoscopy and intubation between patients receiving dexmedetomidine and placebo nebulisation. |