| CTRI Number |
CTRI/2013/06/003741 [Registered on: 12/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
10/06/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
COMPARISION OF EFFECTIVENESS OF DEXMEDETOMIDINE(A MULTIPURPOSE DRUG USED IN ANAESTHESIA) VS ESMOLOL(USED FOR CONTROL OF HIGH BP & HEART RATE) IN DECREASING THE HYPERTENSION & TACHYCARDIA OCCURING DURING PASSAGE OF BREATHING TUBE INTO LUNGS IN PATIENTS WITH HIGH BP WHO ARE ON TREATMENT |
|
Scientific Title of Study
|
COMPARISION OF EFFECTIVENESS OF DEXMEDETOMIDINE VS ESMOLOL IN BLUNTING OF CARDIOVASCULAR RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN TREATED HYPERTENSIVES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KIRAN BHARATH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
ROOM NO:312, NEW DOCTORS HOSTEL,
PGIMER, CHANDIGARH
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE,
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914589448 |
| Fax |
|
| Email |
kbharath2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUBRATA PODDER |
| Designation |
GUIDE TO PRINCIPAL INVESTIGATOR |
| Affiliation |
PGIMER |
| Address |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE,
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209526 |
| Fax |
|
| Email |
podder_s@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
KIRAN BHARATH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
ROOM NO:312, NEW DOCTORS HOSTEL,
PGIMER, CHANDIGARH
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE,
PGIMER, CHANDIGARH
CHANDIGARH
160012
India |
| Phone |
9914589448 |
| Fax |
|
| Email |
kbharath2003@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| KIRAN BHARATH JUNIOR RESIDENT DEPARTMENT OF ANAESTHESIA PGIMER CHANDIGARH |
NEHRU HOSPITALPGIMER |
NEHRU HOSPITAL, PGIMER, SECTOR-12, CHANDIGARH-160012
Chandigarh
CHANDIGARH |
9914589448
-
kbharath2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertensive patients on treatment with good control of blood pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
INJ. DEXMEDETOMIDINE 1µg/kg IV infusion over 10 minutes, to be completed ten minutes before anaesthesia is induced |
| Intervention |
Esmolol |
Inj.ESMOLOL 1mg/kg IV bolus, to be given two minutes before intubation |
| Comparator Agent |
PLACEBO WITH NORMAL SALINE |
EQUAL VOLUME OF NORMAL SALINE IN CONTROL GROUP |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Ninety patients of ASA physical status II & III, of either sex, aged between 35-65 years and undergoing elective surgery requiring general anaesthesia will be included in the study. Controlled hypertensive patients with blood pressure less than 160/100 mmHg receiving oral antihypertensive medication for a minimum period of six weeks will be studied. |
|
| ExclusionCriteria |
| Details |
• Patients with anticipated difficult intubation
• Physical status > ASAIII
• Hiatus hernia, gastro-oesophageal reflux disease
• Obesity ( BMI > 30 kg/m2)
• Those on long-term sedatives, hypnotics, antidepressants, drugs affecting nervous system
• Previous myocardial infarction or angina pectoris, congestive heart failure
• Heart blocks
• Neurosurgical patients
• History of allergy to dexmedetomidine or esmolol
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of dexmedetomidine versus esmolol in blunting of the hemodynamic and bispectral index(BIS) response to laryngoscopy and intubation in treated hypertensive patients undergoing elective surgery |
It will be a randomized double- blind study conducted between january 1st 2011 to December 31st 2011(one year). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study also aims at measuring dexmedetomidine’s effect on isoflurane requirements. |
It will be a randomized double- blind study conducted between january 1st 2011 to December 31st 2011(one year). |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/05/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension and tachycardia are
frequently associated with
direct laryngoscopy and
endotracheal intubation
(LETI) after induction
of anaesthesia. Patients
with hypertension, both
treated and untreated,
are prone to exaggerated
pressor response to
LETI than are
normotensive patients.The
exaggerated pressor response
to LETI in these
patients can evoke
life-threatening condtions which
include myocardial ischemia, pulmonary oedema, cardiac failure and
cerebral haemorrhage. Few studies
have been carried
out with consideration to
attenuate the hemodynamic
response to laryngoscopy
in the subgroup
of patients with
hypertension. Nitroglycerine, verapamil, diltiazem, esmolol, alfentanil and remifentanil have been used of which
esmolol was found to be most effective.
Dexmedetomidine, a clonidine-like α2-agonist
is a sedative-hypnotic and analgesic. The mechanism by which
dexmedetomidine produces its actions is mainly through central sympatholysis
and decreased circulating levels of catecholamines. Since cardiovascular response
to LETI is sympathetically driven, it can be catastrophic, especially in
hypertensives due to their enhanced sensitivity to circulating catecholamines.
It is therefore hypothesised that dexmedetomidine can effectively blunt the
sympatho-adrenal response to LETI, thereby resulting in decreased morbidity in
hypertensive patients. Hence this present study aims to study a new drug
dexmedetomidine against the previously established drug esmolol in blunting of
cardiovascular response to LETI.
|