| CTRI Number |
CTRI/2025/01/079428 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compartive Study of Nebulized Ropivacaine and Nebulized Ropivacaine with dexmedetomidine |
|
Scientific Title of Study
|
A RANDOMIZED STUDY TO COMPARE THE EFFECT OF
NEBULIZED ROPIVACAINE AND NEBULIZED
ROPIVACAINE WITH DEXMEDETOMIDINE
ON ATTENUATING HEMODYNAMIC RESPONSE TO
INTUBATION IN PATIENTS UNDERGOING SURGERY
UNDER 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 |
Ashu Agarwal |
| Designation |
PG student |
| Affiliation |
Jhalawar medical college Jhalawar |
| Address |
Department of Anaesthesia , NH 12 KOTA ROAD JHALAWAR
Jhalawar
RAJASTHAN
326001
India |
| Phone |
9828746500 |
| Fax |
|
| Email |
Ashu98280@gmail.con |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pratibha Rathore |
| Designation |
Proffesor |
| Affiliation |
Jhalawar Medical College Jhalawar |
| Address |
298, BARKAT NAGAR TONK PHATAK JAIPUR
Anaesthesia department , 1 floor , room no 110 ,NH 12 kota rd jhalawar 326001
Jaipur
RAJASTHAN
302015
India |
| Phone |
9414446473 |
| Fax |
|
| Email |
PRATIBHA.RATHORE3@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pratibha Rathore |
| Designation |
Proffesor |
| Affiliation |
Jhalawar Medical College , Jhalwar |
| Address |
298, BARKAT NAGAR TONK PHATAK JAIPUR
Anaesthesia department, 1 floor, room no 110, NH 12 kota rd jhalawar 326001
Jaipur
RAJASTHAN
302015
India |
| Phone |
9414446473 |
| Fax |
|
| Email |
PRATIBHA.RATHORE3@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Jhalawar medical college , Jhalawar,Rajasthan , India, 326001 |
|
|
Primary Sponsor
|
| Name |
Ashu Agarwal |
| Address |
47,Chankya Marg,Karni Colony,Vijay BARI Path no 7 , Sikar Road,Jaipur,Rajathan 302023 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Ashu Agarwal |
Jhalawar Medical College |
Department of Aanesthesia ,1 foor,room no 110, NH 52 Kota Road, Jhalawar,326001
Jhalawar
RAJASTHAN |
9828746500
ashu98280@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Jhalawar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35||Acute appendicitis, (2) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (3) ICD-10 Condition: N25||Disorders resulting from impairedrenal tubular function, (4) ICD-10 Condition: G89-G99||Other disorders of the nervous system, (5) ICD-10 Condition: M97||Periprosthetic fracture around internal prosthetic joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ropivacaine |
Nebulize They Patient With 0.5% Ropivacaine See They Hemodynamic Response they total duration of this study is 1.5 years. |
| Comparator Agent |
Ropivacaine AND Dexemedetomidine |
Nebulize They Patient With Ropivacaine And Dexemedetomidine And See They Hemodynamic Response .They total duration of this study is 1.5 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient giving consent for study
2. Weight 40-70 kg
3. ASA grade 1 & 2
4. Patients undergoing surgery under general anaesthesia
5. All lab investigations within normal range
|
|
| ExclusionCriteria |
| Details |
1. Patient with a history of sore throat or upper respiratory tract infection
2. Hemodynamically unstable patients
3. Emergency patients
4. Patients with a history of allergy to local anesthetics
5. Patents with a history of allergy to dexmedetomidine
6. Patients with a history of cardiac, liver, or renal disorders.
7. Patient with a difficult airway where the anticipated duration of laryngoscopy exceeded 15 seconds.
8. ASA 3 and 4
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| .To access and compare they hemodynamic changes HR , SBP, DBP,MAP, Spo2 and ETco2 in both the groups |
Before Nebulization ,After Nebulization, Before Intubation ,After Intubation, 5 minute after intubation ,at skin closure ,after extubation, 5 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the cough response at extubation in both the groups.
2. The incidence rate of postoperative sore throat. In both the groups.
|
sore throat at time of extubation, 2 hour, 4 hour,6hour,12 hour,24 hour
cought response at time of extubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| 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="3"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 26-11-2024 and end date provided 01-04-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
THIS STUDY IS TO COMAPRE THEY EFFECT OF NEBULIZED ROPIVACAINE AND NEBULIZED ROPIVACAINE WITH DEXMEDETOMIDINE ON THE HEMODYNAMICE RESPONSE TO INTUBATION IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA. PREOPERATIVE VITALS ARE MOINTORED AND BEFORE INTUBATION PATIENTS IS NEBULIZED WITH ONE OF THEY GROPUS AND AFTER NEBULIZATION THEY VITALS ARE MONITORED AND THEY ARE VITALS ARE MOINTORED THROUGH OUT THEY PROCEDURE AT DIFFERENT TIME INTERVAL AND AFTER EXTUBATION PATIENTS IS ACCESED FOR SORE THROAT AND COUGH RESPOSNE . ALL THIS DATA WOULD BE ENTRED IN EXCEL SHEET AND FINAL RESULT WOULD BE CONCULUDED. |