| CTRI Number |
CTRI/2020/03/024299 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
24/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Ketamine Versus Magesium Sulfate Nebulization For Attenuation Of Postoperative Sore Throat in Patients Undergoing Nasal Surgeries |
|
Scientific Title of Study
|
Ketamine Nebulization Versus Magnesium Sulfate Nebulization For Attenuation Of Postoperative Sore Throat In Patients Undergoing Nasal Surgeries- A Prospective Randomised Double Blinded Sudy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SATHYA PRIYA S |
| Designation |
POSTGRADUATE |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department Of Anesthesiology, Sri Ramachandra Institute Of Higher Education And Research, No.1,Sri Ramachandra Nagar, Porur, Chennai, Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9952923887 |
| Fax |
|
| Email |
sathya26692@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SATHYA PRIYA S |
| Designation |
POSTGRADUATE |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department Of Anesthesiology, Sri Ramachandra Institute Of Higher Education And Research, No.1,Sri Ramachandra Nagar, Porur, Chennai, Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9952923887 |
| Fax |
|
| Email |
sathya26692@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKILANDESWARI M |
| Designation |
PROFESSOR OF ANAESTHESIOLOGY |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department Of Anesthesiology, Sri Ramachandra Institute Of Higher Education And Research, No.1,Sri Ramachandra Nagar, Porur, Chennai, Tamilnadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
makilandeswari@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research |
|
|
Primary Sponsor
|
| Name |
Department Of Anesthesiology |
| Address |
Sri Ramachandra Institute Of Higher Education And Research, No 1, Sri Ramachandra Nagar, Porur, Chennai 600116 |
| 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 |
| Sathya priya S |
Sri Ramachandra Institute Of Higher Education And Research |
No1, Sri Ramachandra Nagar, Porur, Chennai, Tamilnadu 600116
Chennai
TAMIL NADU |
9952923887
sathya26692@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai 600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, (2) ICD-10 Condition: J342||Deviated nasal septum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ketamine |
Pre operative nebulization with 50mg Ketamine with 4 ml normal saline, 10 minutes before induction of Anesthesia |
| Comparator Agent |
magnesium Sulfate |
Pre operative nebulization with 250mg Magnesium Sulfate with 4ml normal saline, 10 minutes before induction of Anesthesia |
| Intervention |
Nebulization |
Pre operative nebulization, 10 minutes prior induction of Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective Nasal Surgeries, American Standard Association Class 1 And 2, Patients with Mallampatti grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal, Anticipated difficult airway, Patients with reactive airway disease, Patients with difficult airway who needed more than 3 attempts at intubation |
|
|
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 |
| Attenuation Of Postoperative Sore Throat |
Post extubation: 15 minutes ,30 minutes,1st hour, 2nd hour, 6th hour, 12th hour, 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Presence of cough Hoarseness of voice |
Post extubation: 15 minutes, 30 minutes, 1st hour, 2nd hour, 6th hour, 12th hour, 24th hour |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| 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="6"
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)?
|
|
Brief Summary
|
This study is for comparison of Ketamine Versus Magnesium Sulfate nebulization For Attenuation Of Postoperative sore throat in a patients undergoing nasal surgeries. Postoperative sore throat is one of the most common adverse effects of General Anesthesia, especially in ENT surgeries. Among the various pharmacological interventions used to reduce its incidence, nebulization has been found to be most effective. Both Ketamine and Magnesium Sulfate decreases the incidence of Postoperative sore throat via NMDA receptor antagonism. Hence in this study, pre operative nebulization with Ketamine or magnesium Sulfate is compared to evaluate the efficacy in decreasing the incidence of postoperative sore throat in patients undergoing ENT-nasal surgeries. |