| 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
|
|
|
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
|
|
|
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. |