| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shubhadhamin99@gmail.com].
- 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.
- 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. |