| CTRI Number |
CTRI/2018/12/016791 [Registered on: 28/12/2018] Trial Registered Prospectively |
| Last Modified On: |
27/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the comparative efficacy of two different doses of intravenous labetalol in patients with controlled high blood pressure |
|
Scientific Title of Study
|
Efficacy of Two Different Doses of Labetalol Hydrochloride for Attenuation of Haemodynamic Response to Laryngoscopy and Endotracheal Intubation in Controlled Hypertensive Patients – Prospective Randomized Double Blind Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Bharatkumar Prajapati |
| Designation |
Resident Doctor |
| Affiliation |
Baroda Medical College |
| Address |
Department of Anaesthesiology
Baroda Medical College,S.S.G. Hospital Campus,, jail road, sayajigunj,Vadodara-390001
Department of Anaesthesiology
Baroda Medical College,S.S.G. Hospital Campus,, jail road, sayajigunj,Vadodara-390001
Vadodara
GUJARAT
380026
India |
| Phone |
7874157132 |
| Fax |
|
| Email |
drvishalprajapati01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Modi |
| Designation |
Assistant Professor |
| Affiliation |
Baroda Medical College |
| Address |
Department of Anaesthesiology
Baroda Medical College,S.S.G. Hospital Campus,, jail road, sayajigunj,Vadodara-390001
Vadodara
GUJARAT
390001
India |
| Phone |
9712998276 |
| Fax |
|
| Email |
komaltmodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Modi |
| Designation |
Assistant Professor |
| Affiliation |
Baroda Medical College |
| Address |
Department of Anaesthesiology
Baroda Medical College,S.S.G. Hospital Campus,, jail road, sayajigunj,Vadodara-390001
Vadodara
GUJARAT
390001
India |
| Phone |
9712998276 |
| Fax |
|
| Email |
komaltmodi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of Anaesthesiology
Baroda Medical College,S.S.G. Hospital Campus,, jail road, sayajigunj,Vadodara-390001 |
|
|
Primary Sponsor
|
| Name |
SSG Hospital |
| Address |
Department of Anaesthesiology
Baroda Medical College,S.S.G. Hospital Campus,, jail road, sayajigunj,Vadodara-390001 |
| 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 Komal Modi |
S.S.G. hospital |
Department of Anaesthesiology
Baroda Medical College,S.S.G. Hospital Campus,, jail road, sayajigunj,Vadodara-390001
Vadodara
GUJARAT |
9712998276
komaltmodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Reasearch |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection labetalol hydrochloride 0.30 mg/kg |
this dose o.30 mg/kg is used in one group of patient for attenuation.it is given just once according to weight of the patient after completing three minutes pre oxygenetion and haemodynamic changes are observed for 15 minutes at different interval. |
| Intervention |
injecting injection labetalol hydrochloride before doing laryngoscopy and endotracheal intubation in controlled hypertensive patients. |
before doing laryngoscopy and endotracheal intubation , after completing three minutes pre oxygenetion for general anaesthesia, we give these two different doses ,0.15 mg/kg and 0.30 mg/kg, to the allocatted group.we will observe the stress response to laryngoscopy and endotracheal intubation through monitoring various parameters like heart rate,systolic blood pressure and diastolic blood pressure in our controlled hypertensive patients. |
| Comparator Agent |
Injection labetalol hydrochloride 0.15mg/kg |
this dose o.15 mg/kg is used in one group of patient for attenuation.it is given just once according to weight of the patient after completing three minutes pre oxygenetion and haemodynamic changes are observed for 15 minutes at different interval. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
We include ASA grade II patients posted for planned surgery under general anasthesia requiring orotracheal intubation and having controlled hypertension. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to give consent.
Pregnant and lactating women.
Anticipated difficult airway and obesity(BMI >35).
Patient having allergy to study drug.
Patient with sick sinus syndrome (including sino-atrial block),second or third degree heart block and persistent bradycardia (<45-50 bpm).
Patients is having history of taking medication for any sort of illness like verapamil, diltiazem, digitalis glycosides, clonidine, monoamineoxidase inhibitors (except MOA-B inhibitors) and beta blocker.
Patient with systemic diseases like cardiovascular, respiratory diseases like bronchial asthma and COPD, neurological, psychological, hepatic, untreated phaeochromocytoma,renal disease (diagnosed by clinical judgments and investigations) and on medication of above mentioned diseases.
Time more than 20s or requiring more than two attempts for laryngoscopy and intubation.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Both doses of Labetalol Hydrochloride are expected to attenuate hemodynamic response to laryngoscopy and intubation in dose dependent manner in controlled hypertensive patients. |
Both doses of Labetalol Hydrochloride attenuate hemodynamic response to laryngoscopy and intubation in dose dependent manner in early 20 minutes after doing airway instrumentation in controlled hypertensive patients.as this first this few minutes is very crucial causing complication like myocardial ischemia and cerebrovascular events we will observe the response for this early minutes after airway instrumentation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the different side effect of study drug |
we will obeserve various complication like bradycardia,hypotension,any cardiac arrythmia in the patient till after the giving study drug to the complition of operative procedure. |
|
|
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)
|
28/12/2018 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In
India, the prevalence of hypertension is 28%–32% in the urban population and
27.6% in the rural population.Thus, anaesthesiologists are likely to encounter
more patients with this comorbid illnesses presenting for elective surgery. These patients have high incidence
of cardiac arrhythmias, myocardial ischemia, acute left ventricular failure and
cerebrovascular accidents following intubation. Hypertensive patients exhibit
exaggerated intubation response. Hence, suppression of intubation response is
always desirable.
Hypertensive surges more >20% from baseline are associated with adverse
outcomes and should be urgently treated with the goal of blood pressure
reduction. After going into details of different studies and considering the pro and
cons of different doses, we have decided to compare 0.15 mg/kg and 0.30 mg/kg
for attenuation of stress response to laryngoscopy and intubation in our study. |