| CTRI Number |
CTRI/2022/11/047696 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
24/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of drug dexamethasone 8mg filled in definite airway tube and giving intravenously through cannula, its results
on post operative sorethroat, hoarseness,cough response |
|
Scientific Title of Study
|
Effect of intravenous dexamethasone vs intracuff dexamethasone on incidence and severity
of postoperative sore throat in elective surgical patients – A Prospective Randomised
study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR R SRUJAN GOUD |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ESIC Medical College and Super specialty Hospital Department of
Anesthesiology 1st floor operation theatre complex Sanath nagar
Hyderabad
Hyderabad
TELANGANA
Hyderabad
TELANGANA
500038
India |
| Phone |
7780395335 |
| Fax |
|
| Email |
sruj0029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Greeshma kongara |
| Designation |
Assistant professor |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ESIC Medical College and Super speciality Hospital
Department of
Anaesthesiology
3rd floor operation theatre complex
Sanath nagar
Hyderabad
TELANGANA
Hyderabad
TELANGANA
500038
India |
| Phone |
8179952994 |
| Fax |
|
| Email |
Greeshmakongara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Srujan Goud |
| Designation |
Senior Resident |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ESIC Medical College and Super speciality Hospital Department of
Anaesthesiology 1st floor operation theatre complex Sanath nagar
Hyderabad
Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
7780395335 |
| Fax |
|
| Email |
sruj0029@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL |
| Address |
ESIC Medical College and Super speciality Hospital Department of
Anaesthesiology 1st floor operation theatre complex Sanath nagar
Hyderabad
Telangana 500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR GREESHMA |
ESIC MEDICAL COLLEGE AND SUPER SPECIALITY
SANATH NAGAR HYDERABAD 50038 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR R SRUJAN GOUD |
ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL |
ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL
SANATH NAGAR HYDERABAD 500038
Hyderabad
TELANGANA |
7780395335
sruj0029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC INSTITUTIONAL ETHICS COMMITTEE |
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 |
Intra cuff instillation of
dexamethasone 8mg after intubation |
The dexamethasone 8mg was initially injected to ETT cuff followed by required
volume of distilled water to ensure cuff pressure of 20- 25mmHg. |
| Comparator Agent |
IV Dexamethasone 8mg after intubation and ETT cuff filled with distilled water |
Required volume of DISTILLED WATER INSTILLED in ETT cuff to ensure cuff pressure of 20-25mmHg then IV dexamethasone 8mg administered immediately after intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who provided informed consent for participation in the study
2. Patients aged between 18-65 years of either gender, belonging to American Society of
Anesthesiologists physical status I or II scheduled for neurosurgery |
|
| ExclusionCriteria |
| Details |
Patient refusal
2. already on steroids (systemic or inhaled) and hoarseness of voice
3. Cardiorespiratory compromise
4. Emergency surgeries
5. Anticipated difficult airway
6. Active respiratory tract infections
7. Sustained trauma after intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the incidence and severity of post
operative sorethroat. |
post operative sore throat assesed in
0min,30mins,1 hour,24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect on post operative hoarseness of voice and cough |
assesed in 0min,30min,1hour,24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
26/12/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
intra cuff dexamethasone and intravenous dexamethasone effect on post operative sorethroat and hoarsenes of voice and cough |