| CTRI Number |
CTRI/2017/08/009524 [Registered on: 29/08/2017] Trial Registered Prospectively |
| Last Modified On: |
16/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the role of dexamethasone when given via different routes in preventing sore throat in patients after general anaesthesia. |
|
Scientific Title of Study
|
To compare the efficacy of equal dose of dexamethasone in preventing post anaesthesia sore throat when given via three different routes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
DRPGMC Tanda |
| Address |
Department of Anaesthesia; DRPGMC Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
09418011121 |
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda at Kangra |
| Address |
Department of Anaesthesia;
Dr Rajendra Prasad Govt. Medical college Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Sharma |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda at Kangra |
| Address |
Department of Anaesthesia;
Dr Rajendra Prasad Govt. Medical college Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalini Sharma
Assistant Professor
Deptt. of Anaesthesia
Dr Rajendra Prasad Govt. Medical college Tanda |
|
|
Primary Sponsor
|
| Name |
Shalini Sharma |
| Address |
Department of Anaesthesia; DRPGMC Tanda; Kangra |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shalini Sharma |
Dr. Rajendra Prasad govt. medical college Tanda. |
Department of Anaesthesia;
DRPGMC Tanda
Kangra
HIMACHAL PRADESH |
9418011121
shalini.medico@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone nebulisation. |
All the patients will be nebulised with 4 ml of either normal saline or dexamethasone 8mg(volume 4ml)half an hour prior to surgery in the preoperative room. |
| Intervention |
Dipping the endotracheal tube cuff in dexamethasone. |
The endotracheal tube cuff will be dipped in dexamethasone 8mg or normal saline(total volume 4ml) for 10 min before intubation in 10 ml syringe after taking out the plunger and blocking the open end. |
| Intervention |
Intravenous dexamethasone. |
Intravenous dexamethasone 8mg or normal saline (total volume 4ml)will be given intravenous over 1 minute according to randomization before induction to all the patients. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2 & 3 patients.
Age above 18.
Duration of surgery less than two hours
|
|
| ExclusionCriteria |
| Details |
Patients who are allergic to dexamethasone.
Anticipated difficult intubation.
Patients who need nasogastric tube.
Patients on steroids.
Surgeries requiring manipulation of airway.
Patients with sore throat or hoarseness of voice
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of equal dose of dexamethasone in preventing post anaesthesia sore throat and hoarseness when given via three different routes ie intravenous, nebulisation and after dipping the cuff before intubation. |
24 hourly till discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative nausea and vomiting. |
Every 2 hourly in the post operative period till 24 hours. |
| Requirement of analgesics in post operative period. |
Every 2 hourly till 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="190" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2017 |
| Date of Study Completion (India) |
23/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study will be conducted at DRPGMC Tanda at Kangra. A total of 190 patients posted for surgery under general anaesthesia and requiring endotracheal intubation will be recruited. Dexamethasone will be administered to all the patients in equal doses but via different routes. Efficacy of different routes in preventing post operative sore throat and hoarseness will be assessed at 24 hours. |