| CTRI Number |
CTRI/2025/08/092370 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study Comparing Normal Saline, 2 percentage lignocaine, and 0.75 percentage Ropivacaine for Cuff Inflation in Reducing Sore Throat After General Anaesthesia with Breathing Tube (Endotracheal Intubation) |
|
Scientific Title of Study
|
Effect of intracuff Inflation with Normal Saline versus 2 percentage Lignocaine versus 0.75 percentage Ropivacaine on the incidence of Post-Operative Sore Throat in patients undergoing General Anaesthesia with Endotracheal intubation - A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| RC/2025/28 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRADEEP P |
| Designation |
PG STUDENT |
| Affiliation |
pondicherry institute of medical science |
| Address |
Department of Anaesthesiology pondicherry institute of medical sciences kalathumettupathai,ganapathichettikulam,village no 20,kalapet puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8682972309 |
| Fax |
|
| Email |
p.pradeepdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.S.SIVAKUMAR |
| Designation |
Professor and head of the Department of Anaesthesiology |
| Affiliation |
pondicherry institute of medical science |
| Address |
Department of Anaesthesiology pondicherry institute of medical sciences kalathumettupathai,ganapathichettikulam,village no 20,kalapet puducherry
pondicherry institute of medical sciences kalathumettupathai,ganapathichettikulam,village no 20,kalapet puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9944060676 |
| Fax |
|
| Email |
Siva85dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRADEEP P |
| Designation |
PG student |
| Affiliation |
pondicherry institute of medical science |
| Address |
Department of Anaesthesiology pondicherry institute of medical sciences kalathumettupathai,ganapathichettikulam,village no 20,kalapet puducherry
pondicherry institute of medical sciences kalathumettupathai,ganapathichettikulam,village no 20,kalapet puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8682972309 |
| Fax |
|
| Email |
p.pradeepdoc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
pondicherry institute of medical sciences |
| Address |
pondicherry institute of medical sciences village no.20,kalathumettupathai,ganapathichettikulam kalapet,puducherrry 605014 |
| 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 Pradeep P |
Department of anesthesiology, Pondicherry institute medical sciences |
Pondicherry institute of medical sciences
Kalathumettupathai,
Ganapathichettikulam,
Village No.20, Kalapet,
Puducherry - 605 014,
INDIA.
Pondicherry
PONDICHERRY |
8682972309
p.pradeepdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS institute ethics committe(IEC)e |
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 |
| Intervention |
Intracuff inflation of Local anaesthesia (2 percentage lignocaine,0.75 percentage Ropivacaine) |
Intracuff inflation of single administration of lignocaine and ropivacaine before induction of general anaesthesia |
| Comparator Agent |
Normal saline 0.9 percentage |
The cuff will be inflated with of Normal saline 0.9 percentage . The volume required will be determined individually by performing an air-leak test until no audible leak is heard at 25 cm H2O. Volume required roughly around (10_15ml).route of administration (intracuff inflation via pilot ballon)
Cuff pressure will be transduced and maintained at approximately 25 mmHg throughout the procedure.
Maintained for the entire duration of the surgical procedure 2-3 hours . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective surgeries under General Anaesthesia with endotracheal intubation
2. Aged between 18 and 65 years of either gender
3. Belonging to ASA Physical status I & II (American society of Anaesthesiologists Physical Status)
|
|
| ExclusionCriteria |
| Details |
1. Allergic to local anaesthetics
2. Anticipated difficult airway
3. Undergoing oral, head and neck surgeries
4. Surgeries in prone position
5. Patients with acute/ chronic respiratory diseases and active smoking at present.
6. Pregnant females
7 Patient on chronic pain medications
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of post operative sore throat . |
sore throat measured at the 0,2,4,6,8,24hours of end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the incidence of postoperative cough and hoarsness of voice ,other airway related complications. |
measured at the end of 0,2,4,6,8,24 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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 Yet Recruiting |
| 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
|
Post-operative sore throat (POST) is a common and often underestimated complication following general anesthesia with endotracheal intubation, affecting 20% to 74% of patients. Traditional air-filled endotracheal tube cuffs can lead to increased cuff pressure due to anesthetic gas diffusion, contributing to tracheal mucosal irritation and POST. Using fluid media such as normal saline or local anesthetics like 2% lignocaine and 0.75% ropivacaine for cuff inflation may help stabilize cuff pressure and provide localized analgesia. While lignocaine has been widely studied and shown to reduce POST, limited data exist on the use of ropivacaine, despite its longer duration of action and favorable safety profile. This study aims to compare the effectiveness of intracuff 2% lignocaine versus 0.75% ropivacaine in reducing the incidence and severity of POST, potentially offering improved strategies for enhancing patients comfort after surgery.
|