| CTRI Number |
CTRI/2024/09/073844 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of aspirin and magnesium sulphate gargle for prevention of postoperative sore throat in patients undergoing lumbar laminectomy |
|
Scientific Title of Study
|
Comparative evaluation of aspirin and magnesium sulphate gargles for prevention of postoperative sore throat in patients undergoing lumbar laminectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Kundra |
| 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 PUNJAB 141001 India |
| Phone |
9815608241 |
| Fax |
|
| Email |
sandeepkundra07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sandeep Kundra |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Deapartment of Anaesthesia, Dayanand Medical College and Hospital,Civil lines, Ludhiana,141001 PUNJAB, INDIA
PUNJAB 141001 India |
| Phone |
9815608241 |
| Fax |
|
| Email |
sandeepkundra07@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jaspal Kaur |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Deapartment of Anaesthesia, Dayanand Medical College and Hospital,Civil lines, Ludhiana,141001 PUNJAB, INDIA
PUNJAB 141001 India |
| Phone |
9464896232 |
| Fax |
|
| Email |
kkjaspal2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital Civil Lines, Ludhiana, 141001, Punjab, India. |
|
|
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 Jaspal Kaur |
Dayanand Medical College and Hospital |
Deapartment of Anaesthesia, Dayanand Medical College and Hospital, Civil lines, Ludhiana,141001 PUNJAB, INDIA Ludhiana PUNJAB |
9464896232
kkjaspal2@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: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative evaluation of aspirin and magnesium sulphate gargles for prevention of postoperative sore throat in patients undergoing lumbar laminectomy |
Patients in Group A will recieve Tab ASPIRIN 325MG in 20ml of 5% dextrose for mouth gargles 15 minutes prior to 15 minutes. |
| Comparator Agent |
Comparative evaluation of aspirin and magnesium sulphate gargles for prevention of postoperative sore throat in patients undergoing lumbar laminectomy |
Patients in Group B will recieve 2ml of Magnesium sulphate (50% w/v) in 20 ml of 5% dextrose for mouth gargles 15 minutes prior to induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III patients posted for elective lumbar laminectomy surgery in general anesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Any known hypersenstivity or contraindication to aspirin, magnesium sulphate.
3. Recent H/O Sore throat.
4. Pregnant & lactating mothers.
5. Anticipated difficult intubation, MPS Grade III and IV.
6. Patients receiving chronic treatment with calcium channel blocking drugs or magnesium.
7. Patients on steroids due to any reason.
8. History of reactive airway disease like bronchial asthma or COPD, significant neurological or neuromuscular disorder.
|
|
|
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 |
1.Incidence of sore throat.
2.Severity of sore throat as assessed by NRS and subjective grading score. |
At 1hour,2hour,4hour,12hour and 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of post extubation cough |
At 0hour,1hour,2hour,4hour,12hour and 24hour |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
12/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative sore throat (POST) is a common complication after
endotracheal intubation. POST contributes to discomfort and morbidity for the
patient. POST is the result of local tissue trauma due to laryngoscopy and endotracheal
intubation leading to the inflammation of the pharyngeal mucosa. Aspirin is a
commonly used NSAID which acts by inhibiting the prostaglandin system. Aspirin
gargles have been observed to significantly reduce the incidence and severity
of POST. Magnesium, an NMDA receptor antagonist in a few preliminary studies
has also been seen to reduce POST. However; definitive evidence on the role of
magnesium sulphate gargles for the prevention of POST is lacking. Aim of the
study is to compare the efficacy of gargles with aspirin and magnesium sulphate
for the prevention of
postoperative sore throat in patients undergoing lumbar laminectomy in prone
position. A prospective, randomized, double blinded
study will be conducted on sixty patients of either sex between age group 18 to
65 years belonging to ASA grade I, II and III scheduled
for elective lumbar laminectomy under general anaesthesia. Patients will
be randomly allocated to two groups –Group A and Group B of 30 patients each.
Group A patients will receive gargle solution of tab Aspirin 325mg in 20ml of
5% dextrose while group B patients will receive gargle solution of 2ml
Magnesium sulphate in 20ml of 5% dextrose. In Post anesthesia care unit (PACU),
patients will be evaluated for incidence and severity of sore throat using
Numerical Rating Scale (NRS) and severity grading scale at 1, 2, 4 and 24 hrs
postoperatively. This study will aid
elucidating the role of magnesium sulphate gargles for the prevention of POST. |