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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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