| CTRI Number |
CTRI/2021/10/037562 [Registered on: 26/10/2021] Trial Registered Prospectively |
| Last Modified On: |
25/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A comparitive study of efficacy of two different drug combination in reducing adverse events due to the process of insertion of endotracheal tube into the larynx in hypertensive patient " |
|
Scientific Title of Study
|
"A comparitive study of efficacy of propofol with fentanyl and etomidate with fentanyl in attenuation of hemodynamic response and sequelae of laryngoscopy and endotracheal intubation in hypertensive patients" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam K |
| Designation |
Junior resident |
| Affiliation |
Vijaynagar institute of medical sciences, ballari |
| Address |
Department of anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari, karnataka, 583104, india.
Department of anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari, karnataka, 583104, india.
Bellary
KARNATAKA
583104
India |
| Phone |
8095441788 |
| Fax |
|
| Email |
gautamgauti94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam K |
| Designation |
Junior resident |
| Affiliation |
Vijaynagar institute of medical sciences, ballari |
| Address |
Department of anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari, karnataka, 583104, india.
Department of anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari, karnataka, 583104, india.
Bellary
KARNATAKA
583104
India |
| Phone |
8095441788 |
| Fax |
|
| Email |
gautamgauti94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivasalu D |
| Designation |
Professor |
| Affiliation |
Vijaynagar institute of medical sciences, ballari |
| Address |
Department of anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari, karnataka, 583104, india.
Department of anaesthesiology, vijaynagar institute of medical sciences, contonment, Ballari, karnataka, 583104, india.
Bellary
KARNATAKA
583104
India |
| Phone |
9845224880 |
| Fax |
|
| Email |
drsrinivasd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, major OT complex,vims ballari, |
|
|
Primary Sponsor
|
| Name |
vijaynagar institute of medical sciences |
| Address |
contonment, Ballari, 583104 |
| Type of Sponsor |
Government medical college |
|
|
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 Gautam K |
vijaynagar institute of medical sciences |
Department of anaesthesiology , contonment ballari, karnataka
Bellary
KARNATAKA |
8095441788
gautamgauti94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijaynagar institute of medical sciences ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I10||Essential (primary) hypertension, (3) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group E
|
Inj Etomidate 0.3mg/kg IV stat
Inj Fentanyl 2mcg/kg IV stat
Over 30 seconds |
| Intervention |
Group P |
Inj propofol 2mg/kg IV stat
inj fentanyl 2mcg/kg IV stat
Over 30 seconds |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status II
2.Patients with normal ( modified Mallampatti class I or II ) |
|
| ExclusionCriteria |
| Details |
1.refusal by patients for the procedure
2.ASA physical status 3 and 4
3.uncontrolled hypertension (>160/90mmhg)
4.patient with the history of hypersensitivity to inj propofol and inj etomidate
5.Anticipated difficult airway
6.patient with cardiovascular diseases other than hypertension, epilepsy, renal, hepatic disease
7.Brochial asthma and COPD
8.presence of known primary or secondary adrenal insufficiency or on steroid medication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the hemodynamic response during laryngoscopy and endotracheal intubation using inj propofol with inj fentanyl and inj etomidate with inj fentanyl in hypertensive patients |
basal parameters , pre-induction,after-induction, 1min,2min,3min,5min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effects like pain on injection, myoclonus, nausea, vomiting, ST elevation |
During and after intubation |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and endotracheal intubation during induction of general anaesthesia is associated with stress response which leads to hemodynamic changes that may be exaggerated in patients with hypertension and can have unfavourable outcomes. The principle mechanism in hemodynamic changes during laryngoscopy and intubation are sympathetic stimulation , which results in increased heart rate and blood pressure which is usually transitory , variable and unpredictable . These hemodynamic responses are very well tolerated by healthy individuals but it can be hazardous to those with pre existing hypertension , coronary artery disease or cerebrovascular disease. There are number of studies that have compared the efficacy of various induction agents, opioids, beta blockers , calcium channel blocker in obtundation of stress response and consequent hemodynamic effects during laryngoscopy and endotracheal intubation in nonhypertensive patients. But there is paucity of such studies in hypertensive patients. |