| CTRI Number |
CTRI/2024/02/062487 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
premedication with nebulization to decrease operative anxiety |
|
Scientific Title of Study
|
Comparison of the effectiveness of preoperative dexmedetomidine nebulization versus lignocaine nebulization in attenuation of stress response during direct laryngoscopy and intubation in elective surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran A V |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Associate professor Department of Anesthesiology Mandya Institute
of Medical Sciences Mandya
Mandya
KARNATAKA
571401
India
Mandya
KARNATAKA
571401
India |
| Phone |
8073147191 |
| Fax |
|
| Email |
virupaksha2614@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran A V |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Associate professor Department of Anesthesiology Mandya Institute
of Medical Sciences Mandya
Mandya
KARNATAKA
571401
India
Mandya
KARNATAKA
571401
India |
| Phone |
8073147191 |
| Fax |
|
| Email |
virupaksha2614@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sumayya e |
| Designation |
post graduate student |
| Affiliation |
Mandya institute of medical sciences mandya |
| Address |
Department of Anesthesiology Mandya Institute of Medical Sciences
Mandya
Mandya
KARNATAKA
571401
India
erumban house
erumban kudukku
parambil peedika
676317
malappuram
kerala
Mandya
KARNATAKA
571401
India |
| Phone |
8594026729 |
| Fax |
|
| Email |
sumayyasumie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya institute of medical sciences mandya karnataka 676317 |
|
|
Primary Sponsor
|
| Name |
Dr Kiran A V |
| Address |
Associate professor Department of Anesthesiology Mandya Institute
of Medical Sciences Mandya |
| Type of Sponsor |
Other [associate professor] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sumayya E |
Department of Anesthesiology Mandya Institute
of Medical Sciences Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumayya E |
MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA |
Department of
Anesthesiology
Major OT comolex
Mandya
Institute of Medical
Sciences Mandya
Mandya
KARNATAKA
Mandya
KARNATAKA |
8594026729
sumayyasumie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee mandya institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
1 mcg/kg dexmedetomidine nebulization |
| Comparator Agent |
lignocaine |
1.5 mg/kg lignocaine 2% nebulization given preoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries under general endotracheal anesthesia.
Patients who are giving informed written consent
American society of anaesthesiologist (ASA) grade â… and â…¡
Mallampati â… and â…¡
Patients with body mass index less than 30
|
|
| ExclusionCriteria |
| Details |
History of URTI in previous 2 weeks
History of smoking
Laryngoscopy time more than30 seconds
More than 2 attempts at laryngoscopy and intubation
Patients requiring manipulation of airway or instrumentation like oral airway stylet bougie external laryngeal maneuver
Pregnant patients
Patients with poor cardio pulmonary reserve
Patients who are on antidepressants or antipsychotics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the Effectiveness of Preoperative Dexmedetomidine Nebulization Versus
Lignocaine Nebulization in Attenuation of Stress Response During Direct Laryngoscopy and Intubation
|
baseline followed by post nebulization for 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To describe side effects of nebulized Dexmedetomidine and nebulized Lignocaine |
10 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
primary aim of our study is to Compare the Effectiveness of
Preoperative Dexmedetomidine Nebulization Versus Lignocaine Nebulization in
Attenuation of Stress Response During Direct Laryngoscopy and Intubation.
|