| CTRI Number |
CTRI/2022/07/044386 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO KNOW THE EFFECT OF MAGNESIUM SULPHATE NEBULISATION TO PREVENT POST OPERATIVE SORE THROAT FOLLOWING I-GEL INSERTION FOR GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
TO STUDY THE EFFECT OF MAGNESIUM SULPHATE NEBULISATION IN PREVENTION OF POST-OPERATIVE SORE THROAT FOLLOWING I-GEL INSERTION FOR GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AMITHKUMAR S K |
| Designation |
Post graduate |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
OT Complex, 1st floor, Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9538515170 |
| Fax |
|
| Email |
dr7762@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Kumar |
| Designation |
Associate professor |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
OT Complex, 1st floor, Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AMITHKUMAR S K |
| Designation |
Post graduate |
| Affiliation |
DR B R Ambedkar Medical College and Hospital |
| Address |
OT Complex, 1st floor, Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9538515170 |
| Fax |
|
| Email |
dr7762@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
DR AMITHKUMAR S K |
| Address |
OT Complex,1st floor,Department of Anaesthesiology,DR B R Ambedkar College and Hospital,KG Halli,Bengaluru 560045 |
| 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 AMITHKUMAR S K |
DR B R Ambedkar Medical College and Hospital |
OT Complex,1st floor, Department of Anaesthesiology ,Dr B R Ambedkar Medical College and Hospital,KG Halli,Bengaluru 560045
Bangalore
KARNATAKA |
9538515170
dr7762@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee DR B R Ambedkar Medical College and Hospital |
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 |
Injection magnesium sulphate |
Nebulisation of 250mg of injection magnesium sulphate, once 15minutes before induction,
post operative monitoring till 24hours |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgeries and with ASA PS class 1 and 2 |
|
| ExclusionCriteria |
| Details |
patient refusal, Patient with history of frequent sore throat and asthma, Oral surgeries, chronic obstructive pulmonary disease, head and neck
surgeries, Mallampatti grade 3 and above, Known allergies to study drug, Recent non- steriodal anti-inflammatory drugs NSAID medication those who
received.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Magnesium sulphate nebulization in prevention of post operative sore throat following use of I-gel. |
24 hours post operative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity of hemodynamic variability (blood pressure and pulse rate) |
perioperatively |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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 is a common complaint in patients receiving general anaesthesia to undergo surgical procedures over the years. Irritation and inflammation of the airway is considered the most common cause of post operative sore throat. Magnesium sulphate is a NMDA antagonist with anti inflammatory property which work on peripheral nerve endings in pharyngeal mucosa and can reduce the incidence of post operative sore throat. This study is intended to evaluate and assess the incidence and severity of post operative sore throat following administration of magnesium sulphate to the patients 15 minutes pre-operatively. Incidence and severity of post operative sore throat will be graded on verbal rating scale post operatively along with assessment of any undesirable side effects following usage of supraglottic airway device I-gel to maintain anaesthesia. |