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CTRI Number  CTRI/2019/02/017404 [Registered on: 04/02/2019] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational 
Study Design  Other 
Public Title of Study   A study of anaesthesia practices in children with brain tumor surgeries with monitoring of brain cell activities. 
Scientific Title of Study   A prospective observational study of anaesthesia practices in brain tumor surgeries in paediatric population with neurophysiological monitoring in a tertiary cancer centre 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
3203_Protocol Version 1.1 dated 16.01.2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhakti Trivedi 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820333472  
Fax    
Email  bhaktiamit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhakti Trivedi 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9820333472  
Fax    
Email  bhaktiamit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rekha Bhosale 
Designation  Post Graduate Student 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9987917624  
Fax    
Email  rekhabhosale14@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia, Critical Care and Pain, Tata Mmeorial Hospital, Parel 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, Tata Mmeorial Hospital, Parel 
Type of Sponsor  Research institution and hospital 
 
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 Bhakti Trivedi  Tata Memorial Hospital  Department of Anesthesia Critical care and Pain Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA 		 9820333472

bhaktiamit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C71||Malignant neoplasm of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All patients aged 0-18 yr undergoing Elective/Emergency Brain tumor surgery with Intraoperative neurophysiological monitoring 
 
ExclusionCriteria 
Details  Refusal to consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Audit of current anaesthesia practices in Neurosurgery with Intraoperative neurophysiological monitoring in paediatric population.  Preoperative, Intraoperative and Postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
There is no secondary outcome  NA 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   04/02/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION

 

The use of Intraoperative Neurophysiological monitoring (IONM) is becoming gold standard in specialised neurosurgical centre’s throughout the world.

IONM involve the use of multiple monitoring modalities including Evoked potential such as Somatosensory evoked potential, Motor Evoked Potential, Brainstem auditory evoked potential, Visual evoked potential, Electroencephalography (EEG), Electromyography (EMG).

The use of anaesthetic agents has direct impact on quality of evoked potential elicited during IONM.

A Poorly planned and executed anaesthetic could render EPs useless and lead to poor outcome. By understanding how anaesthetic agents affect various signal, anaesthetist become valuable role player in IONM. As the nervous system is physiologically different in children, anaesthetic management differs in this age group and requires special consideration.

 

AIM & OBJECTIVES

 

We aim to conduct a Prospective Observational Audit of current anaesthesia practices in Neurosurgery with Intraoperative neurophysiological monitoring in paediatric population.

 

STUDY METHODOLOGY

This is Prospective observational audit - Prospectively the anaesthetic notes of all patients aged 0-18 yrs undergoing Elective / Emergency Brain surgery under anaesthesia at Tata Memorial Hospital will be reviewed.

Intra-operative data regarding anaesthesia management like type of anaesthesia ,Type of induction (inhalational/Intravenous), Intraoperative vital monitoring likes (Heart rate, Blood Pressure, Saturation, Temperature, End tidal CO2),  Intraoperative fluid requirement, cumulative doses of anaesthesitic drugs, type of Intraoperative neurophysiological monitoring (Motor evoked potential, sensory evoked potential, BIS, TOF) and intra- op complications (Seizures, Tongue injury, Accidental extubation, Haemodynamic instability, anaphylaxis), post op need of ventilation, will be recorded as per the case record form by investigator.

 

INCLUSION CRITERIA

 

All patients aged 0-18 yr undergoing Elective/Emergency Brain tumor surgery with Intraoperative neurophysiological monitoring.

 

EXCLUSION CRITERIA

 

Refusal to consent

 

END POINTS

 

Following variables will be studied.

1)      Demographics- Age , Sex

2)      Site of disease

3)      Type of surgery, anaesthesia

4)      Duration of anaesthesia, duration of surgery

 

5)   At induction-

 a)Type of drugs & doses used- Intravenous/ Inhaltional

 b)Airway (ETT/LMA)

 c)Position of patient

 

6)   Maintanace of anaesthetia

 a) Type of anaesthetic agent- Intravenous/ Inhalational

 b) Relaxant                            

 c) No of times boluses given – Propofol/ Fentanyl / Relaxant /others

7)   Intraopmonitoring –HR/NIBP/ SPO2/ Capnograph/ urine output

8)   Intraop complication

9)   Total blood loss, blood products

10)  IV fluid

11)  Type of Intraoperative monitoring- MEP/SSEP/BIS/TOF

12)  Satisfaction score of potential by neurophysician?

13)  Post op need of ventilation

 

SAMPLE SIZE

 

A Convenience period of 1 yr has been chosen. No formal sample size calculation has been performed.

Around 30-35 surgeries are carried out each year.

 

ANALYSIS OF THE VARIABLES

 

Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as mean, standard deviations and confidence intervals, and medians and interquartile range, as appropriate. For comparisons, Students t test, the Mann Whitney U test and the chi square test will be used. All test will be two-tailled, and a p-value of < 0.05 will be considered significant. 
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