| CTRI Number |
CTRI/2022/10/046732 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
20/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Prevention of Postextubation Airway events during Robotic pelvic surgeries after giving Dexamethasone by using Laryngeal Ultrasound |
|
Scientific Title of Study
|
Prophylactic Dexamethasone To Prevent Postextubation Airway Events As Predicted By Laryngeal Ultrasound In Robotic Pelvic Surgery - 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 |
Rukhsar Shah |
| Designation |
Secondary DNB Anaesthesia |
| Affiliation |
Max Superspeciality Hospital Saket |
| Address |
Max Superspeciality OT,East block,West block,Max smart hospital
1, 2, PRESS ENCLAVE ROAD
SAKET, NEW DELHI – 110017
South
DELHI
110017
India |
| Phone |
7889439266 |
| Fax |
|
| Email |
rukhsarshah0803@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Nambiath |
| Designation |
Senior Consultant Max superspeciality hospital saket |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL SAKET |
| Address |
Department of anaesthesia,Max Superspeciality hospital saket
1, 2, PRESS ENCLAVE ROAD
SAKET, NEW DELHI – 110017
South
DELHI
110017
India |
| Phone |
9999109402 |
| Fax |
|
| Email |
drnambiath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rukhsar Shah |
| Designation |
Secondary DNB Anaesthesia |
| Affiliation |
Max Superspeciality Hospital Saket |
| Address |
Department of anaesthesia Max Superspecality saket East block, West block
1, 2, PRESS ENCLAVE ROAD
SAKET, NEW DELHI – 110017
South
DELHI
110017
India |
| Phone |
7889439266 |
| Fax |
|
| Email |
rukhsarshah0803@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Superspeciality Hospital Saket |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital |
| Address |
1, 2, PRESS ENCLAVE ROAD
SAKET, NEW DELHI – 110017
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Rukhsar Shah |
Max superspeciality hospital west block |
1, 2, Press Enclave Road
SAKET, NEW DELHI – 110017
South
DELHI |
7889439266
rukhsarshah0803@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max superspeciality hospital saket |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXAMETHASONE |
In case any of our subjects develop clinical signs of edema post extubation, injection Dexamethasone will be administered by the anesthetist who prepared the study syringe, if the study belongs to the control group |
| Comparator Agent |
Prophylactic Dexamethasone to prevent postextubation airway events in robotic surgeries |
IV Dexamethasone 0.1 mg/kg Q 6 Hourly, 2 Doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for Robotic pelvic surgical procedures requiring steep trendelenburg position like Radical prostatectomy, Inguinal LND, Hysterectomy and radical cystectomy
|
|
| ExclusionCriteria |
| Details |
A.Patient refusal
b. Anticipated difficult airway
c. Body Mass Index > 35
d. Uncontrolled diabetic on insulin / FBS > 150 / HbA1c > 9
e. Patients on steroids
f. Albumin less than 3 mg / dl
g. Patients with a history of recent upper respiratory tract infection
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of prophylactic dexamethasone on the incidence of Post Extubation Airway Events in robotic pelvic surgery, as predicted by sonographically-measured airway column width ratio. |
post intubation
pre extubation
1 hour post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To determine the risk factors for development of Post extubation airway event in robotic pelvic surgery.
2)To correlate the development of facial / conjunctival oedema with airway column width ratio
3)To correlate the development of facial / conjunctival oedema with the development of Post extubation airway event
|
post intubation
pre extubation
1 hour post operative |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/11/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To evaluate the effect of prophylactic dexamethasone on the incidence of Post extubation airway events in robotic pelvic surgeries as measured by air column width ratio using ultrasound |