| CTRI Number |
CTRI/2025/11/096951 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing Intravenous and nebulised dexmedetomidine to reduce stress during intubation and sore throat after surgery under general anaesthesia: A Randomised Study |
|
Scientific Title of Study
|
A Randomised prospective study to see the comparison of Intravenous versus nebulised dexmedetomidine for intubation induced sympathoadrenal stress response & post operative sore throat attenuation in patient undergoing General anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVeena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN medical college & hospital |
| Address |
Department of Anaesthesia JLN medical college & hospital Ajmer
Ajmer RAJASTHAN 305001 India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmaiil.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrVeena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN medical college & hospital |
| Address |
Department of Anaesthesia JLN medical college & hospital Ajmer
Ajmer RAJASTHAN 305001 India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmaiil.com |
|
Details of Contact Person Public Query
|
| Name |
DrVeena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN medical college & hospital |
| Address |
Department of Anaesthesia JLN medical college & hospital Ajmer
Ajmer RAJASTHAN 305001 India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmaiil.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology jln medical college and hospital ajmer 305001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology first floor new ot JLN medical college hospital |
| Address |
KALA BAGH AJMER |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Riya Singh Pangaty |
JLN medical college and hospital, Ajmer |
First floor department of anaesthesiology jln medical college & hospital Ajmer RAJASTHAN |
8240969307
pangaty546@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous dexmedetomidine infusion 1microgram/kg over 10 minutes |
To evaluate the haemodynamic response in one group during endotracheal intubation after using 1microgram/kg over 10 minutes dexmedetomidine |
| Comparator Agent |
Nebulised dexmed 1microgram/kg in 3-4 ml of 0.9% saline |
To evaluate the haemodynamic response during endotracheal intubation after using neblulized dexmedetomidine 1microgram/kg in 3-4 ml of 0.9% saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2
Mallampati 1 and 2
Age 18-60 yrs |
|
| ExclusionCriteria |
| Details |
ASA 3 and above
Mallampati 3 and 4
Allergic to drug
Obese |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see haemodynamic response
During endotracheal intubation using iv and nebulised dexmedetomidine and compare efficacy in blunting the symapathoadrenal response. |
To see haemodynamic response
During endotracheal intubation using iv and nebulised dexmedetomidine and compare efficacy in blunting the symapathoadrenal response |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate 24 hr analgesic consumption in both groups,
To compare the postoperative sore throat |
To evaluate 24 hr analgesic consumption in both groups,
To compare the postoperative sore throat in 24 hours |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
20/11/2025 |
| 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 Yet Recruiting |
| 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
|
Comparison of Intravenous versus Nebulised Dexmedetomidine for Intubation Induced Sympathoadrenal Stress Response and Postoperative Sore Throat Attenuation in Patients Undergoing General AnaesthesiaObjective Primary Objective To compare haemodynamic responses to intubation between intravenous and nebulised dexmedetomidine Secondary Objectives To evaluate postoperative sore throat incidence To assess 24 hour analgesic requirements To monitor postoperative sedation levels using RASS To observe and compare any side effects
Study Design Type Hospital based randomised double blind prospective study Sample Size 100 patients divided into two groups Group D Intravenous dexmedetomidine Group N Nebulised dexmedetomidine Study Duration Till completion of sample size after ethics approval
Inclusion Criteria ASA physical status I and II Age between 18 and 60 years Normal airway Consent for general anaesthesia Exclusion Criteria ASA status III or above Difficult airway Obesity Known cardiac respiratory or neurological disease Allergy to study drugs Refusal to participate
Methodology Patients randomly assigned to two groups Group D receives intravenous dexmedetomidine 1 microgram per kg over 10 minutes Group N receives nebulised dexmedetomidine 1 microgram per kg in normal saline Monitoring of HR BP MAP SpO2 and RASS scores pre and post intubation Assessment of postoperative sore throat and analgesic requirement up to 24 hours
Analysis Data analyzed using SPSS software Statistical tests include t test chi square and ANOVA P value less than 0 point 05 considered significant
Ethical Approval Study will be conducted after approval from Institutional Ethics Committee Written informed consent will be taken from all participants Study drug is FDA approved and used under supervision |