| CTRI Number |
CTRI/2024/10/075797 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observing action of Anaesthetic medicines in drug induced sleep endoscopy |
|
Scientific Title of Study
|
An observational prospective study for drug protocol in DISE in Paediatric population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Harris |
| Designation |
PG Registrar |
| Affiliation |
CMC VELLORE |
| Address |
Department of Anaesthesia,
Christian Medical College,
Vellore,
Tamil Nadu
Vellore TAMIL NADU 632004 India |
| Phone |
08283063968 |
| Fax |
|
| Email |
sakshiharris2609@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sathish Kumar Dharmalingam |
| Designation |
Professor |
| Affiliation |
CMC VELLORE |
| Address |
Department of Anaesthesia,
Christian Medical college,
Vellore
Tamil Nadu
632004
Vellore TAMIL NADU 632004 India |
| Phone |
6369379259 |
| Fax |
|
| Email |
drsathish78@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sathish Kumar Dharmalingam |
| Designation |
Professor |
| Affiliation |
CMC VELLORE |
| Address |
Department of Anaesthesia,
Christian Medical college,
Vellore
Tamil Nadu
632004
Vellore TAMIL NADU 632004 India |
| Phone |
6369379259 |
| Fax |
|
| Email |
drsathish78@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institutional fluid research funding, CMC, Vellore
Vellore,
Tamil Nadu 632004 |
|
|
Primary Sponsor
|
| Name |
Institution fluid research funding |
| Address |
Department of Anaesthesia,
Christian Medical college,
Vellore
Tamil Nadu
632004 |
| 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 Sakshi Harris |
CMC VELLORE |
Department of Anaesthesia,
Christian Medical college,
Vellore
Tamil Nadu
632004 Vellore TAMIL NADU |
08283063968
sakshiharris2609@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R065||Mouth breathing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
All patients in above mentioned age groups and less than 30kg weight |
|
| ExclusionCriteria |
| Details |
All patients who donot fall in the inclusion criteria age group and more than 30kg weight |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine optimal dosage of anaesthetic drugs to be administered to paediatric patients undergoing and assess for successful completion of DISE |
January 2024 to June 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify possible side effects associated with the anaesthetic drugs for example- haemodynamic instability, total airway collapse.
2.• To ensure smooth conduct of procedure with the anaesthetic drugs being used. |
January 2024 to June 2025 |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
05/11/2024 |
| 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="1" Months="7" 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
|
The goal of DISE is to determine an anatomic site of obstruction for children with OSA. Literature shows, there is a low rate of agreement on how to perform DISE. Although many institutions have a standard DISE drug protocol, none has been widely accepted. This wide variability of DISE protocol compromises DISE findings which in turn affect patient Management. This study aims at deriving a standard drug protocol to perform DISE at our institution. After pre-operative assessment of patients, the pre-existing medical conditions and drug allergies will be noted and they will be premedicated with Syrup trichloryl 75 mg/kg one hour prior to entry to OR (Operating room). They will be monitored by a pulse oximeter. On receiving the patient in OR, they will be kept in a quiet room with dimmed lights with few people. Child will be induced with inhalational agents (Sevoflurane + Nitrous oxide + Oxygen) and peripheral IV catheter will be placed once patient is in deep plane of anaesthesia. Dexmedetomidine infusion will be administered at 0.5mcgs/kg IV over 10 minutes. Ketofol (ketamine 100-200 mcg/kg/min + propofol 50-100 mcg/kg/min ) will be titrated according to the BIS value between 65-85(8) and attempt to insert scope will be made. Patient vitals (heart rate, respiratory rate, blood pressure, saturation) will be monitored during the procedure and additional use of extra doses of ketofol will be documented. Patient’s sedation level will be monitored using BIS monitor and time taken to complete the study will be documented. Any untoward events or other factors hindering the successful completion of study will be taken into account. Following DISE, the patient will undergo the proposed procedure, adenoidectomy or tonsillectomy according to the standard protocol. If patient is posted only for DISE, patient will be monitored in recovery room and discharged according to modified Aldrete score. |