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Clinical Trial Details (PDF Generation Date :- Wed, 05 Apr 2023 03:33:27 GMT)

CTRI Number CTRI/2019/01/017060 [Registered on: 14/01/2019] - Trial Registered Prospectively

Last Modified On 24/06/2020
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Surgical/Anesthesia
Study Design Randomized, Parallel Group Trial
Public Title of Study The effect of nebulized dexmedetomidine on blood pressures and heart rate during start of
anaesthesia
Scientific Title of The effect of preoperative dexmedetomidine nebulization on hemodynamic response to
Study laryngoscopy and intubation:placebo controlled randomized trial
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name DR SATYAJEET MISRA
Trial Coordinator
(multi-center study) Designation Additional Professor
Affiliation AIIMS Bhubaneswar
Address Room no 409 Academic Block AIIMS Bhubaneswar Dept of
Anaesthesia AIIMS Bhubaneswar
Khordha
ORISSA
751006
India
Phone 9438884048
Fax
Email misrasatyajeet@gmail.com
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name DR SATYAJEET MISRA
Query)
Designation Additional Professor
Affiliation AIIMS Bhubaneswar
Address Room no 409 Academic Block AIIMS Bhubaneswar Dept of
Anaesthesia AIIMS Bhubaneswar
Khordha
ORISSA
751006
India
Phone 9438884048
Fax
Email misrasatyajeet@gmail.com
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name DR SATYAJEET MISRA
Designation Additional Professor
Affiliation AIIMS Bhubaneswar
Address Room no 409 Academic Block AIIMS Bhubaneswar Dept of
Anaesthesia AIIMS Bhubaneswar
Khordha
ORISSA
751006
India

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Phone 9438884048
Fax
Email misrasatyajeet@gmail.com
Source of Monetary or Source of Monetary or Material Support
Material Support
> AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar 751006 Orissa, India
Primary Sponsor Primary Sponsor Details
Name Dr Satyajeet Misra
Address Room 409, Academic Block AIIMS Bhubaneswar
Type of Sponsor Other [Additional Professor, Dept of Anaesthesia, AIIMS
Bhubaneswar]
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Satyajeet Misra AIIMS Bhubaneswar Room No 409 9438884048
Department of
Anaesthesia Academic misrasatyajeet@gmail.c
Block om
Khordha
ORISSA
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Institutional Ethics Approved 26/12/2018 No
Committee
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Medical and Surgical
Intervention / Type Name Details
Comparator Agent
Intervention Dexmedetomidine nebulization 1 microgram/kg
dexmedetomidine in 3-4 ml
normal saline will be
administered as nebulization to
patients 30 minutes before
induction of anaesthesia
Comparator Agent Control(normal saline 3-4 ml normal saline will be
nebulization) administered as nebulization to
patients 30 minutes before
induction of anaesthesia
Inclusion Criteria Inclusion Criteria
Age From 18.00 Year(s)
Age To 60.00 Year(s)
Gender Both
Details Adult patients posted for elective surgery will be recruited into the
trial after obtaining their written informed consent. The
dexmedetomidine group will receive nebulization with 1
microgram/kg dexmedetomidine diluted in 3-4 ml normal saline 30
minutes before induction of anaesthesia. Heart rate and blood

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pressure responses to laryngoscopy and intubation will be recorded

for 10 minutes after laryngoscopy. The normal saline group (control)
will receive nebulization with normal saline (3-4 ml) 30 minutes
before induction of anaesthesia and heart rate and blood pressure
responses to laryngoscopy and intubation will be recorded for 10
minutes after laryngoscopy.
Exclusion Criteria Exclusion Criteria
Details Patients who undergo emergency surgeries, have known or
unanticipated difficult airway and those who are on anti-hypertensive
medications will be excluded from the trial.
Method of Generating Computer generated randomization
Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Participant and Investigator Blinded
Primary Outcome Outcome Timepoints
Changes in heart rate and blood pressure Upto 10 minutes following laryngoscopy
between the two groups
Secondary Outcome Outcome Timepoints
Postoperative nausea and vomiting and sore First 2 hours following surgery
throat
Target Sample Size Total Sample Size=120
Sample Size from India=120
Final Enrollment numbers achieved (Total)=0
Final Enrollment numbers achieved (India)=120
Phase of Trial N/A
Date of First 15/01/2019
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=0
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Korean J Anesthesiol. 2020 May 20. doi: 10.4097/kja.20153.
Brief Summary Laryngoscopy and intubation cause increase in heart rate and blood pressure which may be
harmful in patients with coronary artery, cerebrovascular or intracranial disease. Various drugs like
opioids, beta blockers and calcium channel blockers, local anaesthetic agents and alpha-2 receptor
agonists have been tried to obtund this response with varying degrees of success.
Dexmedetomidine, an alpha-2 receptor agonist, when tried by the intravenous route is effective in
minimizing this response but causes hypotension and bradycardia. Nebulized route will have the
advantage of minimal systemic effects. Thus, it would be of value addition to study whether the
inhaled route of administration of dexmedetomidine is effective in minimizing the hemodynamic
effects of laryngoscopy and intubation without causing the systemic side effects of hypotension and
bradycardia. Till date, no trial has ever studied the effect of nebulized dexmedetomidine on the
hemodynamic response to laryngoscopy and intubation.

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