| CTRI Number |
CTRI/2023/01/048938 [Registered on: 12/01/2023] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
two different drugs have given to attenuate the heamodynamic stress response to laryngoscopy and intubation |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Dexmedetomidine And Labetalol For Attenuation Of Haemodynamic Stress Response To Laryngoscopy And Endotracheal Intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Solanki Yogesh Naranbhai |
| Designation |
3rd year resident |
| Affiliation |
B.J.Medical Collage,Ahmedabad |
| Address |
F3,First Floor,Department Of Anaesthesiology,B.J.Medical College,Civil Hospital ,Asarwa ,Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
8200877199 |
| Fax |
|
| Email |
yogeshsolanki95ys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSeema Gandhi |
| Designation |
Associate Professor |
| Affiliation |
B.J.Medical Collage,Ahmedabad |
| Address |
F3,First Floor,Department Of Anaesthesiology,B.J.Medical College,Civil Hospital ,Asarwa ,Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373192 |
| Fax |
|
| Email |
drseemagandhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSeema Gandhi |
| Designation |
Associate Professor |
| Affiliation |
B.J.Medical Collage,Ahmedabad |
| Address |
F3,First Floor,Department Of Anaesthesiology,B.J.Medical College,Civil Hospital ,Asarwa ,Ahmedabad.
GUJARAT
380016
India |
| Phone |
9426373192 |
| Fax |
|
| Email |
drseemagandhi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Health and family welfare department |
| Address |
7th floor ,new sachivalaya Gandhinagar |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Solanki Yogesh Naranbhai |
Civil hospital Ahmedabad |
4th and 5th floor,Trauma centre , civil hospital, Asarwa, Ahmedabad 380016 Ahmadabad GUJARAT
Ahmadabad
GUJARAT |
8200877199
yogeshsolanki95ys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethics committee, B.J. Medical College and civil hospital, Ahmedabad |
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 |
| Comparator Agent |
Inj.dexmeditomidine hydrochloride |
Inj.dexmedetomidine 0.001mg/kg in 100 ml NS over 10 minutes and will be stopped 5 minutes before induction |
| Comparator Agent |
Inj.Labetalol hydrochloride |
Inj.Labetalol 0.25mg/kg in 10 ml Ns over 5 minutes and will be stopped 5minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18-60 years of both gender
ASA 1 and 2
Undergoing elective surgical procedure requiring general anaesthesia and endotracheal intubation
Written and informed consent.
|
|
| ExclusionCriteria |
| Details |
Patient refusal to participate in the study
Allergy to study medications
Patients with H/o cardiac, respiratory, renal or hepatic dysfunction or failure.
Pregnant females
Patients on Antihypertensive drugs
Patients with difficult intubation and those patients in whom intubation was attempted for more than 30 seconds or 2 attempts.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of attenuation of Haemodynamic stress response to Laryngoscopy and intubation after giving Inj.Labetalol and dexmedetomidine |
Assessment of attenuation of Haemodynamic stress response to Laryngoscopy and intubation after giving Inj.Labetalol and dexmedetomidine by comparing Haemodynamic parameters (HR,SBP,DBP,SPO2)at baseline,after infusion of study drug,after induction of anaesthesia,immediately after intubation,1,3,5,10 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative sedation by Ramsay scale and adverse effects if occurs |
Sedation by Ramsay scale at immediately after intubation and 15min,30 min,1hr,2hr,4hr,6hr |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/01/2023 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
After the study completed |
|
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 has its own set of complications like increase in heart rate , blood pressure, intraocular, and intracranial pressure. The haemodynamic changes stemming from airway instrumentation are due to sympathoadrenal discharge caused by epipharyngeal and parapharyngeal stimulations.
Labetalol is an unique oral and parenteral antihyper- tensive drug that is alpha-1 and nonselective beta-1 and beta-2 adrenergic antagonist.Its overall effect on cardiac output remains unchanged. It reaches its peak effect at 5-15 minutes after intravenous (IV) injection and has 5.9 minutes of redistribution half-life. It decreases BP by lowering systemic vascular resistance (α1-blockade), whereas reflex tachycardia caused by vasodilatation is decreased by β-blockade with unchanging cardiac output.
Dexmedetomidine is a comparatively newer drug and an imidazole derivative and selective alpha 2 adrenergic receptor agonist. Alpha 2 agonists produce hyperpolarization of noradrenergic neurons and suppression of neuronal firing in the locus ceruleus which leads to decreased systemic noradrenaline release resulting in attenuation of sympathoadrenal responses and hemodynamic stability during laryngoscopy and tracheal intubation. |