| CTRI Number |
CTRI/2024/04/065557 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The power of the drug to produce a desired result of cuff around plastic tube inserted into the patients airway with drug after completion of procedure to prevent complication of sore throat |
|
Scientific Title of Study
|
Efficacy of intracuff Dexamethasone on post-operative sore throat : A prospective randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritul Patel |
| Designation |
Post Graduate Resident |
| Affiliation |
Government medical college,Baroda |
| Address |
Department of Anesthesiology , government medical college ,Baroda
SSG Hospital ,Vadodara
Gujarat
390001
india
Vadodara
GUJARAT
390001
India |
| Phone |
9737540757 |
| Fax |
|
| Email |
rituljp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jalpa Balat |
| Designation |
Assistant Professor |
| Affiliation |
Government medical college, Baroda |
| Address |
Department of Anesthesiology
Baroda Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9909967624 |
| Fax |
|
| Email |
jalpadamor53203@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jalpa Balat |
| Designation |
Assistant Professor |
| Affiliation |
Government medical college, Baroda |
| Address |
Department of Anesthesiology
Baroda Medical College, Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9909967624 |
| Fax |
|
| Email |
jalpadamor53203@gmail.com |
|
|
Source of Monetary or Material Support
|
| Depatment of anaesthesiology, Medical college baroda, Vadodara |
|
|
Primary Sponsor
|
| Name |
Government medical college, Baroda |
| Address |
Department of anesthesiology, Baroda medical college, Baroda |
| Type of Sponsor |
Government 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 Ritul Patel |
Government medical college, Baroda |
Department of Anesthesiology, Baroda Medical College, Baroda
Vadodara
GUJARAT |
9737540757
rituljp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research and Post-graduate Research , Baroda medical college |
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 |
Air |
Endotracheal tube cuff to be inflated with air till the cuff leak disappears. |
| Intervention |
Dexamethasone |
Endotracheal tube cuff to be inflated with Dexamethasone (0.1 mg/kg) and add normal saline till the cuff leak disappears. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA I, II, III scheduled for elective surgery
2]Age group between 18 to 60 years
3]Duration of surgery 2 to 3 hours.
|
|
| ExclusionCriteria |
| Details |
1]Patient Refusal.
2]Patients with history of Smoking, Asthma, recent upper/lower respiratory tract infection, Gastroesophageal reflux disease
3]Patients with laryngeal diseases/surgery
4]Patients with history of tracheostomy
5] difficult intubation
6]Increased risk of aspiration, intraoperatively placement of nasogastric tube
7]Pregnancy
8]Oral Packing
9]Prone Position
10] more than 2 attempts of extubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post-operative laryngotracheal morbidities in terms of sore throat, Coughing, Hoarseness of voice, Dysphagia |
At end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1]Number of attempts of intubation
2]Volume of air or Dexamethasone used for inflating the ETT cuff at the time of intubation.
3]Cuff pressure when filled with Dexamethasone or air at the time of intubation.
4]Hemodynamic parameter. |
From baseline till end of procedure
|
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 4 |
|
Date of First Enrollment (India)
|
21/04/2024 |
| 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="6"
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
|
Emergence from general anaesthesia is frequently complicated by endotracheal tube induced coughing, sore throat, hoarseness of voice and dysphagia and can lead to variety of complications like hypertension, tachycardia. Our aim is to compare intra-cuff Dexamethasone is reducing post operative sore throat than Air. ASA I, II, III patients under age group of 18-60 years with duration of surgery between 2-3 hours will be randomized to receive Dexamethasone (n=54) or Air (n=54). AG CUFFFILL syringe used to compare the cuff pressure during intubation and extubation.
|