| CTRI Number |
CTRI/2021/09/036306 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
03/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between dexmedetomidine nebulization and dexamethasone nebulization in decreasing post intubation sore throat. |
|
Scientific Title of Study
|
Pre-operative Dexmedetomidine and Dexamethasone nebulization in attenuating post-operative sore throat due to endotracheal intubation: A comparative clinical 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 Swathy S Iyengar |
| Designation |
Senior Resident |
| Affiliation |
Kempegowda institute of medical sciences and hospital |
| Address |
Department of anaesthesiology and critical care, Kempegowda institute of medical sciences and hospital, KR Road, V V Puram, Bangalore 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9986356548 |
| Fax |
|
| Email |
swathyiyengar85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathy S Iyengar |
| Designation |
Senior Resident |
| Affiliation |
Kempegowda institute of medical sciences and hospital |
| Address |
Department of anaesthesiology and critical care, Kempegowda institute of medical sciences and hospital, KR Road, V V Puram, Bangalore 560004
Department of anaesthesiology and critical care, Kempegowda institute of medical sciences and hospital, KR Road, V V Puram, Bangalore 560004
KARNATAKA
560004
India |
| Phone |
9986356548 |
| Fax |
|
| Email |
swathyiyengar85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathy S Iyengar |
| Designation |
Senior Resident |
| Affiliation |
Kempegowda institute of medical sciences and hospital |
| Address |
Department of anaesthesiology and critical care, Kempegowda institute of medical sciences and hospital, KR Road, V V Puram, Bangalore 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9986356548 |
| Fax |
|
| Email |
swathyiyengar85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempegowda institute of medical sciences and hospital, KR Road, VV Puram, Bangalore 560004 |
|
|
Primary Sponsor
|
| Name |
Kempegowda institute of medical sciences |
| Address |
Department of anaesthesiology and critical care, Kempegowda institute of medical sciences and hospital, KR Road, V V Puram, Bangalore 560004 |
| 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 Swathy S Iyengar |
Kempegowda institute of medical sciences |
Department of anaesthesiology and critical care, Kempegowda institute of medical sciences and hospital, KR Road, V V Puram, Bangalore 560004
Bangalore
KARNATAKA |
9986356548
swathyiyengar85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS institutional ethics committe |
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 |
Effects of Dexamethasone and Dexmedetomidine nebulization on sore throat prevention |
Nebulization drug is given ten minutes prior to intubation and assessment of incidence and severity of sore throat in the first 24 hours post operative period |
| Comparator Agent |
Post extubation sore throat |
severity of sore throat is assessed in the 24 hours post operative period using a 4 point scale |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Age-18-70, both males and females
Patients posted for elective surgeries under GA with endotracheal intubation, lasting < 2hrs duration.
|
|
| ExclusionCriteria |
| Details |
ASA III, IV Patients
Patients with a history of upper respiratory tract infection, Asthma, sore throat.
Anticipated difficult airway with Mallam Pati grade >2
Weight >80kgs, smokers.
Surgeries requiring nasogastric tube insertion
patients undergoing head and neck surgeries.
Patients undergoing surgeries in prone position.
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of post operative sore throat, hoarseness of voice and cough |
assessed in the first 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic changes and level of sedation |
assessed in the first 24 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/09/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
The study drug (dexamethasone 0.1mg/kg or dexmedetomidine 1 mcg/kg) will be delivered using a nebulization mask for 15 mins at
oxygen source at 8L/min 10 min prior to induction. Post nebulization vitals
will be recorded .GA will be induced with standard Anaesthesia
protocol. Injection xylocard 1.5 mg/kg will be given 90 seconds prior to intubation.
Intra-operative hemodynamic monitoring will be done at 0 (post intubation),2,4
,6,8,10 mins after intubation, thereafter every 5 mins intra operative period.
Smooth extubation followed by monitoring every 15 mins in the PACU.
Assessment for the incidence and severity of sore throat, hoarseness of
voice and cough will be carried out using a 4-point scale (0-3) at 0, 2, 4, 6,
12, 24 hrs post extubation. IV Diclofenac 75 mg will be given as rescue analgesic for severe sore
throat. Sedation will be monitored according to Ramsay Sedation score.
Any side effects such as dry mouth, post-operative nausea and vomiting
(PONV), sedation, respiratory depression and hemodynamic instability will be
monitored and be treated accordingly. |