| CTRI Number |
CTRI/2019/05/019172 [Registered on: 16/05/2019] Trial Registered Prospectively |
| Last Modified On: |
15/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to modify harmful blood pressure and heart rate changes during placement of a tube inside windpipe for securing airway with dexmedetomidine and esmolol |
|
Scientific Title of Study
|
Comparative study of hemodynamic responses during laryngoscopy and endotracheal intubation with dexmedetomidine and esmolol |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vigneshwaran C |
| Designation |
Post graduate resident |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Vigneshwaran C,
Post graduate resident,
Department of Anesthesia,
Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894883196 |
| Fax |
|
| Email |
wincmv26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishwanath R Hiremath |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospita |
| Address |
Vishwanath R Hiremath,
Professor,
Department of anesthesia,
Sri Manakula Vinayagar Medical College and Hospital. Kalitheerthalkuppam, Madagadipet,
Pondicherry – 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442934258 |
| Fax |
|
| Email |
vishwanath0506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishwanath R Hiremath |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospita |
| Address |
Vishwanath R Hiremath,
Professor,
Department of anesthesia,
Sri Manakula Vinayagar Medical College and Hospital. Kalitheerthalkuppam, Madagadipet,
Pondicherry – 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442934258 |
| Fax |
|
| Email |
vishwanath0506@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vigneshwaran C,
Post graduate resident,
Department of anesthesia,
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam,
Madagadipet,
Pondicherry- 605107 |
|
|
Primary Sponsor
|
| Name |
Vigneshwaran C |
| Address |
Sri Manakula Vinayagar Medical College and Hospital. Kalitheerthalkuppam, Madagadipet,. Puducherry – 605 107 |
| Type of Sponsor |
Other [Vigneshwaran C] |
|
|
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 |
| Vigneshwaran C |
Sri Manakula Vinayagar Medical College and Hospital |
Department of Anesthesia,
Kalitheerthalkuppam, Madagadipet,
Pondicherry – 605 107
Pondicherry
PONDICHERRY |
9894883196
wincmv26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH- ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I978||Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine 0.75 microgram/kg |
Group D
patients will receive iv bolus of dexmedetomidine 0.75 mcg/kg diluted in 20 ml with normal saline 10 min before induction |
| Intervention |
esmolol 0.75 mg/kg |
Group E patients will receive IV bolus of esmolol 0.75 mg/kg diluted in 20 ml with normal
saline given 2 min before intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
patients with ischemic heart disease, hypertension, Diabetes mellitus, pregnant, anticipated difficult airway, duration of laryngoscopy more than 20 seconds |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the clinical effects of dexmedetomidine and esmolol
SBP,DBP,MAP,Heart rate,SpO2 recording
|
SBP,DBP,MAP,Heart rate,SpO2 recording
At baseline
At 60 sec after infusion of dexmedetomidine/
esmolol
Immediately after induction
At 1 min after intubation
At 3 min after intubation
At 5 min after intubation
At 10 min after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Attenuation of hemodynamic responses during laryngoscopy and endotracheal intubation. |
SBP,DBP,MAP,Heart rate,SpO2 recording
At baseline
at 60 sec after infusion of dexmedetomidine/
esmolol
Immediately after induction
At 1 min after intubation
At 3 min after intubation
At 5 min after intubation
At 10 min after intubation
|
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/05/2019 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Endotracheal intubation has become an integral part of the anaesthetic management, critical care of the patient. Endotracheal intubation and laryngoscopy causes a pressor response characterized by elevation in systolic and diastolic pressure within five seconds of laryngoscopy which further increases during insertion of the tube into the trachea.Such transient but marked sympathetic response manifesting as increase in heart rate (HR), blood pressure may be well-tolerated by normal fit American Society of Anesthesiologists (ASA) 1 patients. But such events are detrimental in individuals who have limited myocardial reserve due to coronary artery disease, cardiac dysrhythmia, cardiomyopathy, congestive heart failure, hypertension, and geriatric population.Tachycardia and hypertension associated with laryngoscopy and endotracheal intubation should be prevented to maintain the delicate balance between myocardial oxygen supply and demand during induction of general anaesthesia. The purpose of this study is to find out whether the bolus injection of dexmedetomidine 0.75mcg/kg given intravenously before 10 min prior to intubation provides consistent protection against pressor response during laryngoscopy and endotracheal intubation when compared with esmolol group and to attenuate the hemodynamic response to laryngoscopy and endotracheal intubation. |