| CTRI Number |
CTRI/2022/07/044460 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A comparison of intranasal dexmedetomidine versus placebo in attenuation of hemodynamic responses to laryngoscopy and intubation |
|
Scientific Title of Study
|
A randomized double-blind controlled study of attenuation of hemodynamic responses to laryngoscopy and intubation after intranasal administration of dexmedetomidine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arya Viswanath |
| Designation |
PG student |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Kidwai memorial institute of oncology, PG ladies hostel, Dr MH Marigowda road, Bengaluru 560029
Krishnakripa House, kanjiramattom, thodupuzha east po, idukki, kerala
Bangalore
KARNATAKA
560029
India |
| Phone |
9620301823 |
| Fax |
|
| Email |
aryavishwan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Ranganath |
| Designation |
Former HOD and Professor, Department of anesthesia and pain relief, KMIO |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Kidwai memorial institute of oncology
Bangalore
KARNATAKA
560029
India |
| Phone |
919880642830 |
| Fax |
|
| Email |
namrang@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Ranganath |
| Designation |
Former HOD and Professor, Department of anesthesia and pain relief, KMIO |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Kidwai memorial institute of oncology
Bangalore
KARNATAKA
560029
India |
| Phone |
919880642830 |
| Fax |
|
| Email |
namrang@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai memorial institute of oncology , Department of anesthesia and pain relief, Dr MH Marigowda Road, Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
Kidwai memorial institute of oncology |
| Address |
Kidwai memorial institute of oncology, Dr MH Marigowda Road, Bengaluru 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Arya Vishwanath |
Kidwai memorial institute of oncology |
Department of anesthesia and pain relief, preoperative monitoring room, room 105, OT building
Bangalore
KARNATAKA |
09620301823
aryavishwan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kidwai memorial institute of oncology ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9 % normal saline |
Intranasal administration of 1 mL normal saline 45 minutes prior to induction |
| Intervention |
Dexmedetomidine |
Intranasal administration of dexmedetomidine at a dose of 1 micrograms/kg body weight 45 minutes prior to induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 to 65 years belonging to ASA status 1 ad 2 with BMI between 18 -25 kgm2 undergoing surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal. Patient with known nasal pathology. History of allergy to study drug or other anesthetic agents.patient with history ischemic heart disease, cerebrovascular accident, or cardiovascular disease. Patient with second or third degree heart blocks. Patients on long term sedatives or anxiolytics. Patients on Anti hypertensive like clonidine, beta blockers, alpha methyl dopa, alpha adrenergic agonists. |
|
|
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 |
| Hemodynamic responses to laryngoscopy and intubation |
60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation, anxioysis |
45 minutes |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
31/07/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dexmedetomidine is a highly selective short acting alpha 2 agonist. It can provide sedative, analgesic, anxioytic effects with minimal respiratory depression. Several studies also suggest efficacy in blunting hemodynamic responses to laryngoscopy and intubation. Since intravenous use has been associated with several cases of sudden cardiac arrest and delayed post operative recovery, we use intranasal route for our study which also is said to have good patient acceptance. We intend to study the attenuation of hemodynamic responses to laryngoscopy and intubation following preoperative intranasal administration of dexmedetomidine 45 minutes prior to laryngoscopy and intubation when given at a dose of 0.5 micrograms per kg. Additionally we also intend to study preoperative anxiolysis and sedative properties of dexmedetomidine when given intranasal. This shall be compared against intranasal administration of saline 45 minutes prior to laryngoscopy and intubation. The study shall be done in a randomized double blinded placebo controlled manner. Statistical tests for significance shall be performed after obtaining the data. |