| CTRI Number |
CTRI/2023/06/053564 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/09/2023 |
| 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
|
Effect of intravenous lignocaine in preventing post operative sorethroat, an intervention study |
|
Scientific Title of Study
|
EFFICACY AND SAFETY OF PERI-OPERATIVE INTRAVENOUS LIGNOCAINE IN PREVENTING THE POST OPERATIVE SORE THROAT – A PLACEBO CONTROLLED STUDY |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANIMARAN P |
| Designation |
RESIDENT ANAESTHESIA |
| Affiliation |
COMMAND HOSPITAL AIRFORCE BANGALORE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , OPERATION THEATRE COMPLEX 2ND FLOOR , OT OFFICE, AGARAM POST, CAMBRIDGE LAYOUT , BANGALORE
Bangalore
KARNATAKA
560047
India |
| Phone |
903968784 |
| Fax |
|
| Email |
dr.manimaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S K MISHRA |
| Designation |
PROFESSOR |
| Affiliation |
COMMAND HOSPITAL AIRFORCE BANGALORE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , OPERATION THEATRE COMPLEX 2ND FLOOR , OT OFFICE, AGARAM POST, CAMBRIDGE LAYOUT , BANGALORE
Bangalore
KARNATAKA
560007
India |
| Phone |
7829024442 |
| Fax |
|
| Email |
mdsatish08@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
MANIMARAN P |
| Designation |
RESIDENT ANAESTHESIA |
| Affiliation |
COMMAND HOSPITAL AIRFORCE BANGALORE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , OPERATION THEATRE COMPLEX 2ND FLOOR , OT OFFICE, AGARAM POST, CAMBRIDGE LAYOUT , BANGALORE
Bangalore
KARNATAKA
560007
India |
| Phone |
903968784 |
| Fax |
|
| Email |
dr.manimaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| COMMAND HOSPITAL AIRFORCE DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , OPERATION THEATRE COMPLEX 2ND FLOOR , OT OFFICE, AGARAM POST, CAMBRIDGE LAYOUT , BANGALORE 560007 |
|
|
Primary Sponsor
|
| Name |
COMMAND HOSPITAL AIRFORCE BANGALORE |
| Address |
COMMAND HOSPITAL AIRFORCE BANGALORE
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , OPERATION THEATRE COMPLEX 2ND FLOOR , OT OFFICE, AGARAM POST, CAMBRIDGE LAYOUT , BANGALORE 560007 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MAJOR MANIMARAN P |
COMMAND HOSPITAL AIRFORCE BANGALORE |
COMMAND HOSPITAL AIRFORCE BANGALORE
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , OPERATION THEATRE COMPLEX 2ND FLOOR , OT OFFICE, AGARAM POST, CAMBRIDGE LAYOUT , BANGALORE 560007
Bangalore
KARNATAKA |
9003968784
dr.manimaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMAND HOSPITAL AIRFORCE BANGALORE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine |
1.5mg/ Kg intravenous dose will be given 90 seconds before intubation only once during the entire study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Patients of either gender, aged between 18 to 65 years, posted for surgeries requiring GA.
- Patients belonged to ASA 1 and 2 will be included
- Patients willing to participate in the study by obtaining the written informed consent
|
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| ExclusionCriteria |
| Details |
- Patients with abnormal coagulation profile or on anticoagulation therapy, severe anaemia, hypovolemia, shock, septicaemia and history of seizure disorder.
- Allergy to the study drug.
- Emergency surgeries
- Smoker , prior history of sore throat
- Patients who are on treatment with inhaled steroids for any condition
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
- Analysing the incidence of Post operative sore throat between lignocaine versus normal saline group.
- Assessing the safety of peri operative intravenous lignocaine in preventing the incidence of sore throat.
- Incidence of dysphagia and cough between lignocaine versus normal saline group
|
specific time at which the outcome will be assessed/estimated i.e.IMMEDIATELY, 6 HR , 12 HR AND 24 HR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analysing the efficacy of peri operative intravenous lignocaine in preventing the incidence of sore throat |
estimated immediately, 6hours , 12 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
Final Enrollment numbers achieved (Total)= "168"
Final Enrollment numbers achieved (India)="168" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2023 |
| Date of Study Completion (India) |
15/09/2023 |
| Date of First Enrollment (Global) |
10/06/2023 |
| Date of Study Completion (Global) |
15/09/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Sore throat after tracheal intubation has been one of the most common postoperative discomforts causing dissatisfaction among the patients. Incidence of post operative sore throat (POST) varies from 30% to 70%.1 Reason behind this is the irritation and inflammation of the airway caused by pressure exerted on the tracheal wall by the endotracheal tube (ETT) inserted during intubation,2 trauma/erosion during intubation and mucosal dehydration.3 Whilst medical staff may concentrate on avoiding problems during surgery, patients will only be aware of postoperative complications whether its minor or the major. Such complications might affect their satisfaction with treatment. Diameter and the pressure of cuff may also influence the prevalence and severity of postoperative sore throat.4 Many non-pharmacological such as laryngeal mask usage had been tried but when the ETT is the only choice in the patients, pharmacological measures to alleviate the incidence and severity of POST with variable success will be taken into consideration.4,5 Many research articles have been mentioned about the prophylactic use of lidocaine, dexamethasone and steroids or the combination of these drugs has been used for this purpose.6,7 Whereas the studies to analyse the efficacy of peri operative intravenous lignocaine are very less. Hence, we would like to conduct a prospective observational study in this regard.
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