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CTRI Number  CTRI/2025/03/082730 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of 0.75% ropivacaine intra tracheal and intra cuff in general anaesthesia for post operative sore throat and cough 
Scientific Title of Study   Comparison of intra-cuff ropivacaine versus intratracheal ropivacaine on the hemodynamic response to endotracheal tube during emergence from general anesthesia: A randomized controlled trial. 
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 Kathija Begam A 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Jawaharlal Nehru Medical College, Nehru Nagar,Belgaum, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  7975310867  
Fax    
Email  kathijaazad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Raghavendra Kalal 
Designation  Assistant Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Jawaharlal Nehru Medical College, Nehru Nagar,Belgaum, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9880712568  
Fax    
Email  dr.raghavendra.kalal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Kathija Begam A 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Jawaharlal Nehru Medical College, Nehru Nagar,Belgaum, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  7975310867  
Fax    
Email  kathijaazad@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical college, Belgaum -590010 
 
Primary Sponsor  
Name  Dr Kathija Begam A 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College,Belgaum-590010 Nehru Nagar, Belgaum, Karnataka-590010 
Type of Sponsor  Other [Self] 
 
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 Kathija Begam A  Jawaharlal Nehru Medical College  2nd Floor,Department of Anaesthesiology
Belgaum
KARNATAKA 
7975310867

kathijaazad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE   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 
Comparator Agent  Comparator agents: Group A:2ml-3ml of 0.75% Ropivacaine intra tracheal before endotracheal intubation Group c: 3ml of 0.75% Intra cuff Ropivacaine after endotracheal intubation.  After general anaesthesia induction, Group A will receive 2ml-3ml of 0.75% ropivacaine intra tracheally using atomizer before endotracheal intubation. Group C will receive 3ml of 0.75% ropivacaine intra cuff after endotracheal intubation. 
Intervention  General anaesthesia  Group A- Patient will be given general anaesthesia, before endotracheal intubation with endotracheal tube, using atomizer 0.75% ropivacaine 2ml -3ml will be sprayed inside the trachea and surgery will be carried out. Group C- patient will be given general anaesthesia, after endo tracheal intubation with endo tracheal tube, pilot ballon (intra cuff) of the tube will be injected with 3ml of 0.75% ropivacaine and surgery will be carried out.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient undergoing various elective surgeries under general anaesthesia.
2. Age between 18-65 years old
3. American Society of Anaesthesiologists (ASA) I & II.
 
 
ExclusionCriteria 
Details  1.Patients known allergic to the local anaesthetic drugs.
2.Patients undergoing emergency procedures.
3. Haemodynamically unstable patients & pregnant patients.
4. Patients with pre-existing sore throat, hoarseness, cough, recent respiratory illness or history of airway hyperactivity
5. Patients with a difficult airway where the anticipated duration of laryngoscopy exceeds 15 seconds.
6. Patients with a history of cardiac, liver or renal diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
HR,BP will be rising during the time of extubation, which will be blunted in this study. Post operative sore throat and cough will not be there.  During extubation to immediated post operative period upto 2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of intra-cuff ropivacaine (0.75%) versus intratracheal instillation of ropivacaine (0.75%) using atomizer on post operative sore throat and cough.  Immediate post operative period 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 1 
Date of First Enrollment (India)   23/03/2025 
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="0"
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  

After shifting the patient inside the operative room, standard ASA monitors will be attached and baseline parameters of heart rate (HR), noninvasive blood pressure (NIBP), continuous electrocardiogram (ECG) and arterial oxygen saturation (SpO2) will be noted. An intravenous line secured with an 18 G cannula, and all patients will be received ringer lactate infusion at a rate of 10 ml/kg/hr.  As per the institutional protocol general anaesthesia induction will be proceeded. All patients will be premedicated with injection IV glycopyrrolate 0.005mg/kg mg and midazolam 0.05 mg/kg Anesthesia will be induced in the supine position with the head on a standard pillow of 7 cm in height. After preoxygenation for three minutes, anesthesia will be induced using propofol 2mg/kg. After checking for the ability to achieve adequate mask ventilation, succinylcholine 2mg/kg will be used to facilitate muscle relaxation.

 

Study procedure in Group A:

When the muscles are completely relaxed, by using a laryngo-tracheal mucosal atomization device 2 mL of study drug (0.75% ropivacaine) instilled intratracheally to allow uniform surface anesthesia. After study drug instillation, the patient will be intubated using endotracheal tube 7.0–7.5 mm ID for female patients and 7.5–8.5 mm ID for male patients. Intubation will be performed by direct laryngoscopy. After ensuring the proper position of the endotracheal tube, the cuff will be inflated with air.

 Study procedure in Group C:  

After achieving complete muscle relaxation, using direct laryngoscopy, patient will be intubated using endotracheal tube of 7.0-7.5 mm ID for female patients and 7.5-8.5mm ID for male patients. After ensuring the proper position of the endotracheal tube, the cuff will be inflated with 3ml of study drug (0.75% ropivacaine).

Surgery will be carried out, during extubation time we want to see the heart rate, blood pressure changes and post operative sore throat and cough will be evaluated. 
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