A study of anaesthesia practices in children with brain tumor surgeries with monitoring of brain cell activities.

Recruiting

• Conditions: Malignant neoplasm of brain,

• Registration Number: CTRI/2019/02/017404
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

**INTRODUCTION**

The use of Intraoperative Neurophysiologicalmonitoring (IONM) is becoming gold standard in specialised neurosurgicalcentre’s throughout the world.

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

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

A Poorly planned and executed anaesthetic could renderEPs useless and lead to poor outcome. By understanding how anaesthetic agentsaffect various signal, anaesthetist become valuable role player in IONM. As thenervous system is physiologically different in children, anaesthetic managementdiffers in this age group and requires special consideration.

 **AIM & OBJECTIVES**

We aim to conduct a Prospective Observational Audit ofcurrent anaesthesia practices in Neurosurgery with Intraoperativeneurophysiological monitoring in paediatric population.

 **STUDY METHODOLOGY**

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

Intra-operative data regarding anaesthesia managementlike type of anaesthesia ,Type of induction (inhalational/Intravenous),Intraoperative vital monitoring likes (Heart rate, Blood Pressure, Saturation, Temperature,End tidal CO2),  Intraoperative fluidrequirement, cumulative doses of anaesthesitic drugs, type of Intraoperative neurophysiologicalmonitoring (Motor evoked potential, sensory evoked potential, BIS, TOF) andintra- op complications (Seizures, Tongue injury, Accidental extubation, Haemodynamicinstability, anaphylaxis), post op need of ventilation, will be recorded as perthe case record form by investigator.

 **INCLUSION CRITERIA**

All patients aged 0-18 yr undergoingElective/Emergency Brain tumor surgery with Intraoperative neurophysiologicalmonitoring.

 **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)   Atinduction-

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

b)Airway(ETT/LMA)

c)Position ofpatient

 6)   Maintanaceof anaesthetia

a) Type of anaestheticagent- Intravenous/ Inhalational

b) Relaxant

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

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

8)   Intraopcomplication

9)   Total bloodloss, blood products

10)  IV fluid

11)  Type ofIntraoperative monitoring- MEP/SSEP/BIS/TOF

12)  Satisfactionscore of potential by neurophysician?

13)  Post opneed of ventilation

 **SAMPLE SIZE**

A Convenience period of 1 yr has been chosen. Noformal sample size calculation has been performed.

Around 30-35 surgeries are carried out each year.

 **ANALYSIS OF THEVARIABLES**

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Last Update Posted: 2019-11-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

Refusal to consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Audit of current anaesthesia practices in Neurosurgery with Intraoperative neurophysiological monitoring in paediatric population.	Preoperative, Intraoperative and Postoperative

Secondary Outcome Measures

Name	Time	Method
There is no secondary outcome	NA

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Bhakti Trivedi

Principal investigator

9820333472

bhaktiamit@gmail.com