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CTRI Number  CTRI/2024/11/076745 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Comparison of nebulised ropivacaine with nebulised dexmedetomidine and nebulised lignocaine in patients undergoing surgery under general anaesthesia 
Scientific Title of Study   Comparison of Nebulised Ropivacaine 0.75 percent Versus Nebulised Dexmedetomidine and Nebulised lignocaine 4 percentin patients undergoing surgery under General Anesthesia. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aysath nuhaimah 
Designation  Post graduate resident of anaesthesiology  
Affiliation  B.j medical college , Sassoon hospital 
Address  Major surgery department, bjmc , sassoon hospital , Agarkar nagar , jay Prakash road, pune, maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  8848150750  
Fax    
Email  ayshanaheema@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aysath nuhaimah 
Designation  Post graduate resident of anaesthesiology  
Affiliation  B.j medical college , Sassoon hospital 
Address  Major surgery department,sassoon hospital , Agarkar nagar , jay Prakash road, pune, maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  8848150750  
Fax    
Email  ayshanaheema@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kshirsagar sujit 
Designation  Assistant professor 
Affiliation  Bjmc and sasoon hospital  
Address  Infosys building, bj medical college, Sassoon hospital, pune

Pune
MAHARASHTRA
411001
India 
Phone  8983741147  
Fax    
Email  bjsujit@gmail.com  
 
Source of Monetary or Material Support  
Bjmedical college and Sassoon hospital , pune, maharashtra, 411001 
 
Primary Sponsor
Modification(s)  
Name  Aysath nuhaimah 
Address  COVIDIEN building, sassoon hospital, jay Prakash road, Agarkar nagar, pune, maharashtra, 411001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aysath nuhaimah  Sassoon hospital  Operation theatre and preoperative room , bjmc, sassoon hospital, jay Prakash road, Agarkar nagar, pune, Maharashtra.
Pune
MAHARASHTRA 		 8848150750

ayshanaheema@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BJMC and SGH PUNE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug ropivacaine 0.75%, lignocaine , dexmedetomidine  Nebulisation is given Using ultrasonic nebuliser preoperatively and observe the haemodynamic changes at the time intubation , extubation and cough response at the time of extubation 
Comparator Agent  Drugs comparison with nebulised 0.75% ropivacaine, nebulised 4 % lignocaine, nebulised dexmedetomidine 1 microgram perkg  Nebulisation given and comparation between thaw hemodynamic changes at intubation and extubation and cough response 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA grade I and II
2. Non- hypertensive
3.Non obese
4.MPC I and II
5.Surgeries lasting for at least upto 2 hours and not beyond 4 hours.
6. Elective surgeries 
 
ExclusionCriteria 
Details  1.Patients who refused to participate in study
2.patients age is less than 18 and not more than 60 years.
3. Patients with nasogastric tube.
4.Contraindication for the use of nitrous oxide.
5.Mallampati classification III and IV
6.hypertensive patients
7.ASA III AND IV
8.Patients with history of allergy to dexmedetomidine.
9.Daycare surgeries.
10. Patients with difficult airway where the anticipated duration of laryngoscopy exceeded 15 seconds.
11. Emergency surgeries.’
12.Patients with history of cardiac,liver or renal disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Monitor the hemodynamic changes in patients received ultrasonic nebulisation 4 % lignocaine at 10 minutes before and after nebulisation, 10 min, 20 minutes , 30 minutes till 120 minutes after intubation
Monitor the hemodynamic changes of patients received ultrasonic nebulisation of dexmedetomidine 1 micro gram per kg at 10 minutes before and after nebulisation.
10 minutes, 20 minutes, 30 minutes till 90 minutes after intubation.
Monitor hemodynamic changes in patients received ultrasonic nebulisation of 0.75 % ropivacaine at 10 minutes before and after nebulisation.
10 minutes, 20 minutes till 90 minutes after intubation.
 		 Observed assessed by 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic parameters of nebulised ropivacaine versus nebulised lignocaine versus nebulised dexmedetomidine at extubation
With 24 hours.
Compare the cough response at the extubation and incidence of rate of postoperative sore throat 		 Observed assessed by 12 weeks 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   23/02/2025 
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="25"
Months="2"
Days="25" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 Not yet any publication done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ayshanaheema@gmail.com].

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 01-03-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 This is a prospective, comparative study to monitor the hemodynamic changes in patients received nebulisation lignocaine 4%, dexmedetomidine 1 microgram /kg  at the time of intubation , extubation and any cough response.
The response at noted in tabular form and being observed
 
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