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CTRI Number  CTRI/2025/11/097954 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of adding Dexmedetomidine to nebulised Ropivacaine on hemodynamic response to intubation 
Scientific Title of Study   Comparitive study on the effect of nebulised ropivacaine with or without dexmedetomine on hemodynamic response during intubation in surgery 
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 Shubhadha D Amin 
Designation  Junior Resident 
Affiliation  M S Ramaiah Medical College  
Address  Department of Anaesthesiology M S Ramaiah Medical College MSRIT Post New BEL road Bangalore 560054

Bangalore
KARNATAKA
560054
India 
Phone  8296553155  
Fax    
Email  shubhadhamin99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navdeep 
Designation  Associate professor 
Affiliation  M S Ramaiah Medical College  
Address  Department of Anaesthesiology M S Ramaiah Medical College MSRIT Post New BEL road Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9945557290  
Fax    
Email  nvdepkaur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Navdeep 
Designation  Associate professor 
Affiliation  M S Ramaiah Medical College  
Address  Department of Anaesthesiology M S Ramaiah Medical College MSRIT Post New BEL road Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9945557290  
Fax    
Email  nvdepkaur@gmail.com  
 
Source of Monetary or Material Support  
MS Ramaiah medical college MSRIT Post New Bel road Bangalore 560054 
 
Primary Sponsor  
Name  MS Ramaiah medical college 
Address  MSRIT Post New Bel road Bangalore 560054 
Type of Sponsor  Private 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 Shubhadha D Amin  MS Ramaiah Medical college and hospital   Department of Anaesthesiology MS Ramaiah Medical College MSRIT Post New BEL Road Bangalore 560064 Bangalore KARNATAKA
Bangalore
KARNATAKA 
8296553155
-
shubhadhamin99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MS Ramaiah Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H604||Cholesteatoma of external ear, (2) ICD-10 Condition: H652||Chronic serous otitis media, (3) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (4) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, (5) ICD-10 Condition: H663||Other chronic suppurative otitis media, (6) ICD-10 Condition: H681||Obstruction of Eustachian tube, (7) ICD-10 Condition: H701||Chronic mastoiditis, (8) ICD-10 Condition: H710||Cholesteatoma of attic, (9) ICD-10 Condition: H711||Cholesteatoma of tympanum, (10) ICD-10 Condition: H712||Cholesteatoma of mastoid, (11) ICD-10 Condition: H720||Central perforation of tympanic membrane, (12) ICD-10 Condition: H721||Attic perforation of tympanic membrane, (13) ICD-10 Condition: H800||Otosclerosis involving oval window, nonobliterative, (14) ICD-10 Condition: H801||Otosclerosis involving oval window, obliterative, (15) ICD-10 Condition: H802||Cochlear otosclerosis, (16) ICD-10 Condition: J340||Abscess, furuncle and carbuncle ofnose, (17) ICD-10 Condition: J341||Cyst and mucocele of nose and nasal sinus, (18) ICD-10 Condition: J342||Deviated nasal septum, (19) ICD-10 Condition: J343||Hypertrophy of nasal turbinates, (20) ICD-10 Condition: J330||Polyp of nasal cavity, (21) ICD-10 Condition: J331||Polypoid sinus degeneration, (22) ICD-10 Condition: J338||Other polyp of sinus, (23) ICD-10 Condition: J351||Hypertrophy of tonsils, (24) ICD-10 Condition: J352||Hypertrophy of adenoids, (25) ICD-10 Condition: J36||Peritonsillar abscess, (26) ICD-10 Condition: J381||Polyp of vocal cord and larynx, (27) ICD-10 Condition: J382||Nodules of vocal cords, (28) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (29) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (30) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (31) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ropivacaine 0.75%  Ropivacaine 0.75% 5ml with 5ml normal saline given as nebulisation for 10mins , 30 mins before the induction of anesthesia  
Comparator Agent  Ropivacaine 0.75% 5ml combined with Dexmedetomidine (1mcg/kg)  Ropivacaine 0.75% 5ml combined with Dexmedetomidine (1mcg/kg) and normal saline given as nebulisation for 10mis, 30mins before induction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of Anaesthesiologists ASA physical status 1 and 2
patients undergoing elective surgeries under general anesthesia  
 
ExclusionCriteria 
Details  - American society of Anaesthesiologists ASA physical status III/IV
- Hemodynamically unstable
- h/o recent sore throat / URTI/ LRTI
- h/o allergy to Ropivacaine
- h/o allergy to Dexmedetomidine
- patients with cardiac, renal, liver disorders
- anticipated difficult airway 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects on hemodynamic response with
nebulised Ropivacaine with or without Dexmedetomidine during intubation in patients
undergoing surgery under general anaesthesia. 
Hemodynamic parameters (HR, SBP, DBP, and MAP) will be
monitored and recorded at 1, 3, 5, 10, and 15 minutes following intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative incidence of sore throat
- Post operative sedation score 
5,10,15,30 minutes after extubation 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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)   15/12/2025 
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="2"
Months="0"
Days="0" 
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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shubhadhamin99@gmail.com].

  6. For how long will this data be available start date provided 11-10-2027 and end date provided 11-11-2032?
    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  
The larynx is a structure richly innervated with abundant neurovascular supply. In general
anaesthesia, while laryngoscopy and endotracheal intubation is done, it triggers significant
hemodynamic response which is pressor response. This can lead to hypertension and tachycardia.
This is due to activation of somatovisceral reflex. Sympatho adrenal stimulus leads to the
release of catecholamines which results in increase in hemodynamics. This can cause
potential complications like cardiac ischaemia, irregular heart rhythm, cerebral bleed etc.
Duration and intensity of intubation directly affects the body catecholamine response
typically begins within 5 to 10s and peeks at 1 to 2 mins and returns to baseline within 5 mins.
These are tolerated by healthy individuals and can cause complications in susceptible
patients.
Ropivacaine is a long-acting amide local anaesthetic has its ability to block nociceptive
stimuli at peripheral nerves. Using Ropivacaine as a local anaesthetic during intubation can
help mitigate hemodynamic fluctuations and cough response during extubation due to its
longer duration of action.
Dexmedetomidine is a highly selective centrally acting alpha 2 agonist with sedative,
anxiolytic, hypnotic, perioperative sympatholytic, and anaesthetic sparing effects that reduce
central sympathetic outflow and attenuate the stress response associated with surgery
providing good perioperative hemodynamic stability. Its commonly associated with systemic
side effects such as hypotension, bradycardia.

Nebulization offers increased bioavailability. 65 percent nasal mucosa absorption and 82 percent via 
buccal mucosa absorption. Nebulized Dexmedetomidine has a short half life of 6 mins and
elimination half life of 2hrs without being associated with systemic side effects.
In the present study, our primary aim is to evaluate and compare the hemodynamic response
during intubation following the pre treatment with nebulised Ropivacaine alone versus a
combination of nebulised Ropivacaine and Dexmedetomidine.
In the present study we hypothesise that combining Dexmedetomidine and Ropivacaine
results in a more effective suppression of the pressor response than using Ropivacaine by
itself.
 
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