| CTRI Number |
CTRI/2022/09/045879 [Registered on: 26/09/2022] Trial Registered Prospectively |
| Last Modified On: |
05/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To Know The Effect Of Magnesium Sulphate Nebulisation And Ketamine 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 And Ketamine 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 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, K G Halli, Bengaluru Bangalore
KARNATAKA
560045
India
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@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, K G Halli, Bengaluru Bangalore
KARNATAKA
560045
India
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, K G Halli, Bengaluru Bangalore
KARNATAKA
560045
India
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 SANTOSH KUMAR |
| Address |
OT Complex, 1st floor, Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, K G Halli, Bengaluru Bangalore
KARNATAKA
560045
India |
| 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 SANTOSH KUMAR |
DR B R Ambedkar Medical College and Hospital |
OT Complex, 1st floor, Department of Anaesthesiology, DR B R Ambedkar Medical College and Hospital, K G Halli, Bengaluru Bangalore
KARNATAKA
560045
India
Bangalore
KARNATAKA |
9845785715
drsantoshkumarcc@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 |
| Comparator Agent |
Ketamine nebulization 50mg |
The effect of ketamine nebulization 15 minutes prior to induction is analysed to prevent post operative sore throat following igel insertion in general anaesthesia cases |
| Intervention |
Magnesium sulphate nebulization 225mg |
The effect of magnesium sulphate nebulisation 15 minutes prior to induction is analysed to prevent post operative sore throat following igel insertion in general anaesthesia cases |
|
|
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevention of post operative sore throat following use of I-gel after magnesium sulphate nebulisation or ketamine nebulization |
Sore throat will assessed at 0th hour, 2nd hour, 4th hour and 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess hemodynamic changes (blood pressure and pulse rate) after nebulization intraoperative |
Assessed at 0th, 5,10,15,20,25,30,35,40,45,50,60th minutes after the start of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/09/2022 |
| 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 Yet Recruiting |
| 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 and Ketamine 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 and ketamine 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 the assessment of any undesirable side effects following usage of supraglottic airway device I-gel to maintain anaesthesia.
|