| CTRI Number |
CTRI/2026/02/102792 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
RANDOMIZED TRIAL |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Nebulized Ropivacaine (0.75%) With Nebulized Dexmedetomidine on the hemodynamic response to intubation in patients undergoing General anesthesia. |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL TRIAL TO COMPARE NEBULIZED ROPIVACAINE (0.75 percent) WITH NEBULIZED DEXMEDETOMIDINE ON THE HEMODYNAMIC RESPONSE TO INTUBATION IN PATIENTS UNDERGOING 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 |
Dr. Archana |
| Designation |
Junior Resident |
| Affiliation |
SHRI B.M. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Shri B.M. Patil Medical College, Hospital & Research Centre,
Smt. Bangaramma Sajjan Campus, B.M. Patil Road (Sholapur Road),
Vijayapura (Bijapur) - 586103,
Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
09884027703 |
| Fax |
|
| Email |
archusudha14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vidya Patil |
| Designation |
PROFESSOR |
| Affiliation |
SHRI B.M. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Shri B.M. Patil Medical College, Hospital & Research Centre,
Smt. Bangaramma Sajjan Campus, B.M. Patil Road (Sholapur Road),
Vijayapura (Bijapur) - 586103,
Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448131260 |
| Fax |
|
| Email |
Vidyapatila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vidya Patil |
| Designation |
PROFESSOR |
| Affiliation |
SHRI B.M. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Shri B.M. Patil Medical College, Hospital & Research Centre,
Smt. Bangaramma Sajjan Campus, B.M. Patil Road (Sholapur Road),
Vijayapura (Bijapur) - 586103,
Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448131260 |
| Fax |
|
| Email |
Vidyapatila@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI B.M. PATIL Medical College Hospital and Research Center
DEPARTMENT OF ANESTHESIOLOGY
3RD Floor OT COMPLEX
Vijayapura
Karnataka- 586103 |
|
|
Primary Sponsor
|
| Name |
Dr Archana |
| Address |
SHRI B.M. PATIL Medical College Hospital and Research Center
DEPARTMENT OF ANESTHESIOLOGY
3RD Floor OT COMPLEX
Vijayapura
Karnataka- 586103
India |
| 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 |
| Dr Archana |
SHRI B.M. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
DEPARTMENT OF ANESTHESIOLOGY
3RD FLOOR OT COMPLEX
Bijapur
KARNATAKA |
09884027703
archusudha14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE( DEEMED TO BE UNIVERSITY ) INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R09||Symptoms and signs involving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug given through Nebulization route with Dexmedetomidine (1 mcg/kg) in patients undergoing surgeries under general anesthesia |
Patients are administered with Nebulization Dexmedetomidine (1mcg/kg) in the preoperative ward for 15 mins prior to intubation via NIDEK NEBULUZER with 100% oxygen at 10 liters for 5-7 mins in a propped-up position. The parameters observed before, after intubation, immediately and 5 minutes after extubation are HEART RATE, SYSTOLIC BLOOD PRESSURE, DIASTOLIC BLOOD PRESSURE AND MEAN ARTERIAL PRESSURE. The parameters observed at the time of extubation are COUGH and POST-OPERATIVE SORE THROAT. |
| Comparator Agent |
Drug given through Nebulization route with Ropivacaine (0.75%) in patients undergoing surgeries under general anesthesia |
Patients are administered with nebulization ropivacaine (0.75%) in the preoperative ward for 15 mins prior to intubation via NIDEK NEBULUZER with 100% oxygen at 10 liters for 5-7 mins in a propped-up position. The parameters observed before, after intubation, immediately and 5 minutes after extubation are HEART RATE, SYSTOLIC BLOOD PRESSURE, DIASTOLIC BLOOD PRESSURE AND MEAN ARTERIAL PRESSURE. The parameters observed at the time of extubation are COUGH and POST OPERATIVE SORE THROAT. |
| Intervention |
During the nebulization process |
The oversees nebulization and whole procedure and can intervene if any side effects such as bradycardia , coughing and increased sedation occurs. If such side effects occurs, the investigator will stop the procedure and adequate symptomatic intervention will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
It includes
patients with ASA grade 1 and 2
patients with Mallampati grade 1 and 2
elective surgeries with duration of less than 120 mins |
|
| ExclusionCriteria |
| Details |
it excludes
hemodynamically unstable patients
patients with history of sore throat or upper respiratory tract infection
patients with allergy to local anesthetics and dexmedetomidine
patients with history of cardiac, liver and renal disorders
patients with difficult airway where a laryngoscopy is expected to take more than 15 seconds
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the effectiveness of nebulized Ropivacaine (0.75%) and nebulized Dexmedetomidine in attenuating the hemodynamic response during laryngoscopy and endotracheal intubation |
THE HEMODYNAMIC RESPONSE MEASURED
T0- baseline before nebulization
T1- immediately after nebulization
T2- before tracheal intubation
T3- immediately after tracheal intubation
T4 - 5 minutes after tracheal intubation
T5- at the closure of the skin incision
T6- immediately after tracheal extubation
T7-5 minutes after tracheal extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO ASSESS
1.THE HEMODYNAMIC PARAMETERS AT EXTUBATION
2. COUGH RESPONSE AT EXTUBATION
3. INCIDENCE RATE OF POST OPERATIVE SORE THROAT AFTER EXTUBATION |
1.Immediately & 5minutes after extubation
2. COUGH RESPONSE at 0, 5 AND 30 MINUTES
3. POSTOPERATIVE SORE THROAT at - 0,2,4,6,12 AND 24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
10/02/2026 |
| 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="6"
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 - NO
|
|
Brief Summary
|
All patients included in the study will undergo General physical examination, airway assessment and systemic examination will be done and consent will be taken one day prior to the study. Standard monitoring of hemodynamic parameters (blood pressure, pulse rate, saturation, respiration rate) are done in the preoperative room. On the day of surgery patients are divided into 2 groups with 64 patients each. GROUP D received NEBULIZED DEXMEDETOMIDINE (1mcg/kg) with normal saline 5 ml and GROUP R will receive NEBULIZED ROPIVACAINE (0.75%) 5ml.Patients will receive nebulization 15mins prior to the intubation. Patients are connected to the monitors as per as American Society of Anesthesiologist classification (ASA) guidelines and baseline parameters are monitored in the operative room. Patients are induced according to institutional policy and laryngoscopy should not exceed more than 15 seconds. The primary aim of the study is to compare the hemodynamic response with nebulized dexmedetomidine and nebulized ropivacaine and accordingly parameters are measured at various time points like - baseline before and after nebulization, before and after tracheal intubation, minutes after tracheal intubation, at the time of skin closure and immediately and 5 minutes after tracheal extubation. The secondary aim of the study is to compare the hemodynamic parameters at extubation, and to compare the cough response to extubation and the incidence rate of postoperative sore throat. Any adverse effects in the perioperative period will be managed as per the institutional policy. |