CTRI Number |
CTRI/2022/09/045139 [Registered on: 01/09/2022] Trial Registered Prospectively |
Last Modified On: |
27/08/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Case Control Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Effect of Dexmedetomidine nebulisation to reduce the blood pressure following Endotracheal intubation. |
Scientific Title of Study
|
Effect of preanaesthetic dexmedetomidine nebulization in hemodynamic responses following laryngoscopy and intubation |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deeksha B G |
Designation |
Post Graduate |
Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE HOSPITAL |
Address |
OT complex 1st floor, Dr BR Ambedkar medical College, KG Halli , Bangalore KADUGONDANAHALLI BENGALURU 560045 Bangalore KARNATAKA 560045 India |
Phone |
9480175763 |
Fax |
|
Email |
deekshambbs@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Reshma B M |
Designation |
Associate professor |
Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE HOSPITAL |
Address |
OT complex 1st floor, Dr BR Ambedkar medical College, KG Halli , Bangalore KADUGONDANAHALLI BENGALURU 560045 Bangalore KARNATAKA 560045 India |
Phone |
8892019120 |
Fax |
|
Email |
lucky3276@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Deeksha B G |
Designation |
Post Graduate |
Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE HOSPITAL |
Address |
OT complex 1st floor, Dr BR Ambedkar medical College, KG Halli , Bangalore KADUGONDANAHALLI BENGALURU 560045 Bangalore KARNATAKA 560045 India |
Phone |
9480175763 |
Fax |
|
Email |
deekshambbs@gmail.com |
|
Source of Monetary or Material Support
|
Dr. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
|
Primary Sponsor
|
Name |
Dr Deeksha B G |
Address |
OT complex, department of anaesthesia, Dr. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE |
Type of Sponsor |
Other [Self ] |
|
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 Deeksha |
Ot complex |
Dr. B. R. Ambedkar medical College and hospital, Bangalore Bangalore KARNATAKA |
9480175763
deekshambbs@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institution Ethics Committee Dr BR Ambedkar Medical College |
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 |
Dexmedetomidine nebulisation |
Patients posted for surgery under general anaesthesia with Endotracheal intubation will be given dexmedetomidine nebulization 1mcg/kg body weight 45min before intubation |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
All patients posted for surgery under general anaesthesia with Endotracheal intubation
|
|
ExclusionCriteria |
Details |
Patients with Difficult Airway
Pregnancy and Lactation |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To study the effect of pre operative dexmedetomidine nebulization on mean arterial pressure following laryngoscopy and intubation |
First 5 minutes and 10th minute following laryngoscopy and intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Changes in the heart rate
Following laryngoscopy and intubation |
At first 5 minutes and 10th minute following laryngoscopy and intubation |
Sedation score |
Pre operatively from the start of nebulization till end of nebulization for every 5 minutes |
Total doses of propofol used |
At the time of induction |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
05/09/2022 |
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
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Direct laryngoscopy and intubation are noxious stimuli and are associated with transient but unpredictable and variable haemodynamic changes. This response occurs within 30 seconds after intubation and lasts less than 10 minutes. The consequences of laryngoscopy and intubation may precipitate ischemia, arrhythmias, cerebrovascular stroke, pulmonary oedema, increase in intracranial pressure in vulnerable group. Till date, numerous drugs and various routes have been tried to attenuate this stress response such as opioids, vasodilators, beta blockers, calcium channel blockers, intravenous lignocaine but none of the agents proved to be ideal. Dexmedetomidine is a highly selective alpha 2 adrenoreceptor agonist. It is a short acting drug having sympatholytic, sedative, hypnotic, anxiolytic, analgesic and anti-sialogogue properties. Its pleiotropic effect have led to its increasing use for reducing anaesthesia and analgesic requirements in the perioperative period.
The efficacy of dexmedetomidine in attenuating the hemodynamic response to laryngoscopy and intubation has been studied through intravenous, intranasal and intramuscular routes. However, it is noted that intravenous administration causes bradycardia, hypotension and even cardiac arrest [2] and intranasal administration may be associated with nasal irritation, cough, vocal cord irritation or laryngospasm. Inhalation of nebulized drug is an alternative method of administration that is relatively easy to set up, does not require venipuncture, and is associated with high bioavailability of the administered drug.
Nebulised dexmedetomidine has been used as an effective premedication in paediatric patients in the doses of 1 and 2mcg/kg. Few studies are available which have evaluated either 1 or 2 mcg/kg dexmedetomidine in attenuating stress response to intubation. Hence, our study and we hypothesize that dexmedetomidine nebulisation at 1 mcg/kg provides good haemodynamic stability and sedation. |