| CTRI Number |
CTRI/2024/04/066293 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To prevent postoperative sore throat using pre-operative gargle. |
|
Scientific Title of Study
|
Comparative study of magnesium and ketamine
gargle to prevent postoperative sore throat. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishnuvanditha Vuppuluri |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College |
| Address |
Dept of Anesthesia
Saveetha Medical College and Hospital
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
|
| Fax |
|
| Email |
vishnuvanditha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi R |
| Designation |
Head of Department |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Anesthesiology, 2nd floor,
Saveetha Medical College and Hospital
Chennai
TAMIL NADU
602105
India |
| Phone |
9380535766 |
| Fax |
|
| Email |
rajalakshmidrkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishnuvanditha Vuppuluri |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Dept of anesthesia
Saveetha Medical College and Hospital
Chennai
TAMIL NADU
602105
India |
| Phone |
09543389991 |
| Fax |
|
| Email |
vishnuvanditha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, 162, Poonamallee Highroad, Thandalam, Kancheepuram -602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College |
| Address |
Saveetha Medical College Hospital, 162, Poonamallee High road, Thandalam, Kancheepuram - 602105 |
| 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 |
| Vishnuvanditha Vuppuluri |
Saveetha Medical College and Hospital |
Department of Anesthesiology,
2nd floor,
Saveetha Medical College,
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Kancheepuram
TAMIL NADU |
9543389991
vishnuvanditha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMCH - IEC |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2
AGE 18 0 60 YEARS
ELECTIVE PROCEDURES |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of sore throat in patient going general anesthesia with endotracheal tube |
Immediate post extubation, end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of nausea |
Immediate Post extubation, end of surgery |
| To compare incidence of vomiting |
Immediate Post extubation, end of surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the effect of magnesium sulfate and ketamine gargle on the incidence and severity of postoperative sore throatIn this study, we aim to compare the effect of magnesium sulfate and ketamine gargle on the incidence and severity of postoperative sore throat. To study the incidence and severity of sore throat using 10 point scale. To study any adverse effects of voice,cough, nausea, vomiting and hypothermia. |