| 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 Study
|
The effect of preoperative dexmedetomidine nebulization on hemodynamic response to laryngoscopy and intubation:placebo controlled randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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 |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Scientific 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 |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact 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 |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar
Sijua, Patrapada
Bhubaneswar 751006
Orissa, India |
|
|
Primary Sponsor
|
| 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 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 Satyajeet Misra |
AIIMS Bhubaneswar |
Room No 409
Department of Anaesthesia
Academic Block
Khordha
ORISSA |
9438884048
misrasatyajeet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Control(normal saline nebulization) |
3-4 ml normal saline will be administered as nebulization to patients 30 minutes before induction of anaesthesia |
| 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 |
|
|
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 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. |
|
| ExclusionCriteria |
| 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 Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in heart rate and blood pressure between the two groups |
Upto 10 minutes following laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative nausea and vomiting and sore throat |
First 2 hours following surgery |
|
|
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 Enrollment (India)
|
15/01/2019 |
| Date of Study Completion (India) |
09/01/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Korean J Anesthesiol. 2020 May 20. doi: 10.4097/kja.20153. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |