| CTRI Number |
CTRI/2024/02/063147 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing heart rate and blood pressure with inhaled dexmedetomidine and magnesium sulfate in surgeries under general anesthesia |
|
Scientific Title of Study
|
Comparision of Nebulized Dexmedetomidine Versus Nebulized Magnesium Sulfate for Attenuation of Hemodynamic Stress Response to Laryngoscopy and Tracheal Intubation in Elective Surgical Cases Under General Anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran A V |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anesthesiology Mandya Institute of Medical Sciences
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
8867917802 |
| Fax |
|
| Email |
virupaksha2614@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran A V |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anesthesiology Mandya Institute of Medical Sciences
Mandya
KARNATAKA
571401
India |
| Phone |
8867917802 |
| Fax |
|
| Email |
virupaksha2614@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran A V |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anesthesiology Mandya Institute of Medical Sciences
Mandya
KARNATAKA
571401
India |
| Phone |
8867917802 |
| Fax |
|
| Email |
virupaksha2614@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical Sciences, Mandya |
|
|
Primary Sponsor
|
| Name |
Dr Kiran A V |
| Address |
Department of Anesthesiology Mandya Institute of Medical Sciences
Mandya |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Surabhi C A |
Post Graduate student Department of Anesthesiology
Mandya Institute of Medical sciences
Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surabhi C A |
Mandya Institute of Medical Sciences |
Department of Anesthesiology Mandya Institute of Medical Sciences
Mandya
Mandya
KARNATAKA |
9663754310
surabhiairani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee |
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 |
Nebulized Dexmedetomidine versus Nebulized Magnesium sulfate |
Comparing hemodynamic stress response to laryngoscopy with MacIntosh Blade and tracheal intubation in patients posted for elective surgeries under general anesthesia with dexmedetomidine 1mcg/kg and magnesium sulfate 30mg/kg via nebulization 30 minutes before intubation in the pre operative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Mallampati grade I and II
BMI 18.5 to 24.9 kg per meter square
patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
history of upper respiratory tract infection in previous 2 weeks
baseline heart rate less than 60 beats per minute
baseline systolic blood pressure less than 60 mm Hg
patients on any medications altering study parameters
pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare hemodynamic stress response to laryngoscopy and tracheal intubation between the groups |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to describe adverse effects of study drugs |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We have formulated this study to compare nebulized dexmedetomidine versus nebulized magnesium sulfate in attenuating hemodynamic stress response to laryngoscopy and tracheal intubation in elective surgical cases under general anesthesia. As studies comparing nebulization with dexmedetomidine and magnesium sulfate to attenuate hemodynamic stress response to laryngoscopy and tracheal intubation are sparse, we formulated this study to find out which among the two in its nebulized form will be better |