| CTRI Number |
CTRI/2024/06/069618 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to comparatively evaluate the efficacy of add on chlorhexidine with lignocaine gargles for prevention of post operative sore throat after ambu auragain laryngeal mask airway insertion |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of add on chlorhexidine with lignocaine gargles for prevention of post operative sore throat after ambu auragain laryngeal mask airway insertion |
| 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 Kamakshi Garg |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814444121 |
| Fax |
|
| Email |
drkamakshigarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan Bhatia |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9592255071 |
| Fax |
|
| Email |
Gunjanbhatia061@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjan Bhatia |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9592255071 |
| Fax |
|
| Email |
Gunjanbhatia061@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India |
| 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 Kamakshi Garg |
Dayanad Medical College and Hospital |
Department of
Anaesthesia Dayanand
Medical College and
Hospital Tagore Nagar,
Civil Lines Ludhiana
PUNJAB 141001
Ludhiana
PUNJAB |
9814444121
drkamakshigarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee, dayanand medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative evaluation of efficacy of add on chlorhexidine with lignocaine gargles for prevention of post operative sore throat after ambu auragain LMA insertion |
This study will be conducted in a prospective,randomized ,single blinded manner.One hundred sixty patients of either sex between age group 18 to 65 years belonging to American Society of Anesthesiologists physical status I, II, and III scheduled for elective surgeries not exceeding 3 hours under general anaesthesia will be randomly allocated into two groups of 80 patients each usingAmbuAuragain laryngeal mask airway.Patients will be randomly allocated into two groups , Group Cand Group L of 80 patients each using computer generated random number list which will be kept in sealed opaque envelop and opened at the completion of study. The study solution will be prepared and administered by the anaesthesia resident who will not take further part in the management of patient. Patients in both the groups will gargle the study solution for 30 seconds, 15 minutes before the induction of anaesthesia.Group C- Patients will receive gargle solution of15 ml of 2%lignocaine viscous with5 ml chlorhexidine.
GroupL– Patients will receive gargle solution of
15 ml of 2% lignocaine viscous with 5 ml normal saline.
The anaesthesia resident monitoring the patient in post anaesthesia care unit (PACU) will not be aware about the group allocation.In the postanaesthesia care unit (PACU), all patients will be evaluated for POST at 0,1, 2, 4, 12 and 24 hrs which will be graded using 4-point scale.
GRADE0 – no sore throat,
GRADE 1 –mild ;complains of sore throat only on asking,
GRADE 2 –moderate; complains of sore throat on their own and
GRADE 3 – severe; change of voice or hoarseness associated with throat pain
Severe and moderate POST will be managed with the nebulisation of normal saline. |
| Intervention |
To check efficacy of add on chlorhexidine with lignocaine gargles for prevention of post operative sore throat after insertion of ambu auragain LMA insertion |
Group C- Patients will receive gargle solution of15 ml of 2%lignocaine viscous with5 ml chlorhexidine.
GroupL– Patients will receive gargle solution of
15 ml of 2% lignocaine viscous with 5 ml normal saline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients of age 18-65 years of either sex posted for elective
procedure not more than 3 hours duration under general
anaesthesia with AmbuAuragain LMA.
2 American Society Of Anaesthesiologists (ASA) status I, II and III. |
|
| ExclusionCriteria |
| Details |
1 Smokers
2 Any known contraindication or hypersensitivity to study drugs.
3 Preoperative sore throat
4 Upper or lower respiratory tract infection
5 Anticipated difficult intubation
6 Risk of aspiration(full stomach, history of gastroesophageal reflex disease, hiatus hernia)
7 Morbid obesity ; BMI > 35 kg/m2
8 Derranged coagulation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Incidence and severity ( subjective grading score ) of sore throat in Group C (lignocaine +chlorhexidine) and Group
L (lignocaine + Normal saline). |
In the postanaesthesia care unit (PACU), all patients will be evaluated for post operative sore throat at 0,1, 2, 4, 12 and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative side effects if any like nausea/vomiting , sedation,bleeding from oral cavity will be noted. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Post operative sore throat is one of the most common post-operative complication with an incidence of 65%. Many pharmacological and non pharmacologicaltherapeutic measures have been tested to prevent POST with variable results. We used AmbuAuragaineLMA in this study as it is easy to insert,less invasive and is associated with minimal haemodynamic response and fewer complications compared to ETT. A total of 160 adult patients (18-65 years age) ASA I,II and III undergoing surgery in general anaesthesia with Ambu Auragain LMA will be enrolled in this prospective randomized study.Patients will be allocated into two groups Group C (viscous lignocaine+chlorhexidine) and Group L (viscous lignocaine+normal saline) of 80 patients each.list.Group C will receive 15ml of 2% xylocaine viscous with 5 ml chlorhexidine and group L will receive 15ml of 2% xylocaine viscous with 5 ml normal saline as gargle solution 15 minutes before the induction of anaesthesia for 30 seconds. In the operation theatre after standard anaesthesia induction Ambu Auragain LMA will be inserted. Incidence of post-operative sore throat will be evaluated using a 4- point scale at 0h,1h,2h,4h,12h and 24h in post anaesthesia care unit (PACU). |