| CTRI Number |
CTRI/2021/08/035859 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
magnesium sulfate nebulisation in reducing the post
operative sore throat after intubation |
|
Scientific Title of Study
|
Evalution of effect of nebulised magnesium sulfate in reducing the post
operative sore throat in patients undergoing surgery under General
Anaesthesia with Endotracheal tube intubation |
| Trial Acronym |
MK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujithra K |
| Designation |
Postgraduate |
| Affiliation |
chettinad health city and research institute |
| Address |
First floor OT A Block,chettinad hospital and Research Institute,Rajiv Gandhi Salai,
Kelambakkam.
Chennai
TAMIL NADU
603103
India |
| Phone |
9843834400 |
| Fax |
|
| Email |
sujithrakandeepan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ashok Kulasekar |
| Designation |
Professor |
| Affiliation |
chettinad health city and research institute |
| Address |
First floor OT Department of anesthesia,chettinad hospital and research institute
Rajiv Gandhi Salai,
Kelambakkam.
Chennai
TAMIL NADU
603 103
India |
| Phone |
9840498420 |
| Fax |
|
| Email |
ashokk_dr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujithra K |
| Designation |
Postgraduate |
| Affiliation |
chettinad hospital and research and institute |
| Address |
First floor OT,Deoartment if Anaesthesiology A Block,chettinad hospital and Research Institute,
Rajiv gandhi salai ,
kelambakkam.
Chennai
TAMIL NADU
603103
India |
| Phone |
9843834400 |
| Fax |
|
| Email |
sujithrakandeepan@gmail.com |
|
|
Source of Monetary or Material Support
|
| chettinad hospital and research institute |
|
|
Primary Sponsor
|
| Name |
chettinad hospital and research institute |
| Address |
chettinad health city,Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sujithra K |
Chettinad hospital and research institute |
1st Floor,operation theater complex,Chettinad hospital and research institute,Rajiv gandhi salai,Kelambakkam.
Chennai
TAMIL NADU |
9843834400
sujithrakandeepan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad academy of research and education institutional human ethics committee |
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 |
Magnesium sulfate |
Magnesium sulfate of 400mg (0.8ml+2.2ml NS)will be nebulized over 20 minutes in the preoperative patient recieving area |
| Comparator Agent |
Normal saline |
Normal saline (3ml) will be nebulized over 20 minutes in the preoperative patient recieving area |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Amercian society of anethesiologist grade 1,2 patients undergoing surgery under general anethesia with endotracheal tube intubation |
|
| ExclusionCriteria |
| Details |
uncontrolled diabetic ,hypertension
ischemic heart disease
known allergy to drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the effect of nebulized magnesium sulfate in reducing post operative sore throat following general anethesia with endotracheal tube intubation |
till 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the severity of sore throat
to find the hemodynamic changes in both the group |
severity will be assessed upto 24hrs |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
30/08/2021 |
| 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="11"
Days="2" |
|
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
|
This study aims to reduce the postoperative sore throat following endotracheal tube intubation by performing a simple nebulisation before induction of general anethesia and improve the quality of postoperative care. |