| CTRI Number |
CTRI/2023/08/057074 [Registered on: 30/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON BETWEEN NEBULIZATION WITH DEXAMETHASONE AND NEBULIZATION WITH KETAMINE TO PREVENT POST OPERATIVE SORE THROAT IN PATIENTS UNDERGOING ENDOTRACHEAL INTUBATION. |
|
Scientific Title of Study
|
COMPARISON OF PREOPERATIVE NEBULIZATION WITH DEXAMETHASONE VERSUS KETAMINE TO PREVENT POST OPERATIVE SORE THROAT IN PATIENTS UNDERGOING GENERAL ANAESTHESIA WITH ENDOTRACHEAL INTUBATION:A RANDOMISED DOUBLE BLIND STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KUDARY NEETHI PRIYANKA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE |
| Address |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,SANT TUKARAM NAGAR, PIMPRI ,PUNE
DEPARTMENT OF ANESTHESIA,
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,SANT TUKARAM NAGAR, PIMPRI ,PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
7601087425 |
| Fax |
|
| Email |
neethipriyankakudary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BHAVINI SHAH |
| Designation |
PROFFESSOR |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA, DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,SANT TUKARAM NAGAR, PIMPRI ,PUNE
DEPARTMENT OF ANAESTHESIA,DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,SANT TUKARAM NAGAR, PIMPRI ,PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
7601087425 |
| Fax |
|
| Email |
drbhavini.shah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KUDARY NEETHI PRIYANKA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR.D.Y.PATIL MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE |
| Address |
DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,SANT TUKARAM NAGAR, PIMPRI ,PUNE
DEPARTMENT OF ANAESTHESIA, DR.D.Y.PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,SANT TUKARAM NAGAR, PIMPRI ,PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
7601087425 |
| Fax |
|
| Email |
neethipriyankakudary@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL PHARMACY,HIGHTECH OT ,5TH FLOOR |
|
|
Primary Sponsor
|
| Name |
Dr KUDARY NEETHI PRIYANKA |
| Address |
Dr.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ,SANT TUKARAM NAGAR PIMPRI,PUNE,411018 |
| 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 |
| Dr KUDARY NEETHI PRIYANKA |
Dr.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE |
HITECH OT COMPLEX,5TH FLOOR,HIGHTECH BUILDING
Pune
MAHARASHTRA |
7601087425
neethipriyankakudary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS SUB-COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 AND ASA II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NEBULIZATION |
COMPARISON OF PREOPERATIVE NEBULIZATION WITH DEXAMETHASONE VERSUS KETAMINE TO PREVENT POST OPERATIVE SORE THROAT IN PATIENTS UNDERGOING GENERAL ANAESTHESIA WITH ENDOTRACHEAL INTUBATION:A RANDOMISED DOUBLE BLIND STUDY. |
| Comparator Agent |
NEBULIZATION WITH DEXAMETHASONE |
NEBULIZATION WITH DEXAMETHASONE TO PREVENT POST OPERATIVE SORE THROAT IN
PATIENTS UNDERGOING GENERAL ANAESTHESIA WITH ENDOTRACHEAL
INTUBATION |
| Comparator Agent |
NEBULIZATION WITH KETAMINE |
NEBULIZATION WITH KETAMINE TO PREVENT POST OPERATIVE SORE THROAT IN
PATIENTS UNDERGOING GENERAL ANAESTHESIA WITH ENDOTRACHEAL
INTUBATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 to 60 years
2. American Society of Anaesthesiology (ASA) grade I and II
3. Hemodynamically stable patients with all routine investigations within the normal limits
requiring GA with endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. Patient with a history of pre operative upper respiratory tract infection
2. History of asthma, recent use of non-steroidal anti inflammatory drugs
3. Undergoing head and neck surgeries, oral, nasal and surgeries in prone position .
4. MPC lll and lV patients
5. Enlisted patients who needed more than one intubation attempt or developed any intra
operative or post operative complication
6. Known allergy to study drug. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of preoperative nebulization of Dexamethasone for prevention of POST in patients undergoing general anaesthesia with endotracheal intubation. |
AFTER EXTUBATION,AFTER 2HOURS,AFTER 4HOURS,AFTER 6HOURS,AFTER 12HOURS AND AFTER 24HOURS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of preoperative nebulization of Ketamine for prevention of POST in patients undergoing general anaesthesia with endotracheal intubation. |
AFTER EXTUBATION,AFTER 2HOURS,AFTER 4HOURS,AFTER 6HOURS,AFTER 12HOURS AND AFTER 24HOURS. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
11/09/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a randomized, prospective, comparative, double binded, observational study where preoperative nebulization with dexamethasone and preoperative nebulization with ketamine are compared to reduce post operative sore throat in patients undergoing general anaesthesia with endotracheal intubation. |