| CTRI Number |
CTRI/2022/10/046174 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| 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
|
A Drug Named Dexmedetomidine Will Be Used In Inhalational Form Into Your Breathing System To Blunt The Stress Response Which Occurs While Putting A Tube Through The Mouth Into The Breathing System Before Surgery |
|
Scientific Title of Study
|
Effect Of Preoperative Dexmedetomidine Nebulization in Controlling Postintubation Haemodynamic And Stress Response In Adults Undergoing Elective Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna S |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ,VMMC AND SAFDARJUNG HOSPITAL NEW DELHI
New Delhi
DELHI
110049
India |
| Phone |
9986971935 |
| Fax |
|
| Email |
Krishnasampath273@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ameeta Sahni |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ,VMMC AND SAFDARJUNG HOSPITAL NEW DELHI
New Delhi
DELHI
110049
India |
| Phone |
9811201585 |
| Fax |
|
| Email |
ameetaas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna S |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY ,VMMC AND SAFDARJUNG HOSPITAL NEW DELHI
New Delhi
DELHI
110049
India |
| Phone |
9986971935 |
| Fax |
|
| Email |
Krishnasampath273@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Ansari nagar east, opposite to AIIMS, New Delhi -110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ameeta Sahni |
VMMC And Safdarjung hospital New delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna s |
VMMC AND SAFDARJUNG HOSPITAL NEW DELHI |
Department of Anaesthesia,Main OT Complex,
New Delhi
DELHI |
9986971935
Krishnasampath273@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulization with Normal Saline |
Patients will be Nebulized with Normal Saline preoperatively to compare with the interventional drug |
| Intervention |
Nebulized Dexmedetomidine |
Nebulized Dexmedetomidine will be given preoperatively to blunt the stress response to intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults of age group from 18 to 65 years undergoing elective surgeries
ASA grade 1 patients |
|
| ExclusionCriteria |
| Details |
Age group less than 18 years and more than 65 years
History of hypersensitivity to Dexmedetomidine
Pregnancy
Patient on psychiatric medications, on steroid therapy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Haemodynamic parameters such as heart rate, Blood pressure,Mean arterial pressure.To determine cortisol levels 10minutes post intubation |
Measurement of heart rate, Blood pressure, Mean arterial pressure at 0,3,5,10 minutes after intubation. Measurement of cortisol levels at 10 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine cortisol levels 10 minutes post intubation |
Measurement of cortisol levels at 10 minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Adult Patients Undergoing Elective Surgeries will be Nebulized with Dexmedetomidine of dose 0.6 mcg/kg preoperatively to blunt the stress response to endotracheal intubation and hemodynamic parameters such as heart rate, blood pressure will be noted at various time intervals. Also baseline serum cortisol will be estimated and also serum cortisol levels will be noted 10minutes after intubation to evaluate the stress response to intubation |