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CTRI Number  CTRI/2022/07/044376 [Registered on: 27/07/2022] Trial Registered Prospectively
Last Modified On: 22/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Correlation of Preoperative anxiety and requirement of anaesthetic depth in children 
Scientific Title of Study   Correlation of preoperative anxiety using modified Yale preoperative anxiety scale and requirement of anaesthetic depth using bispectral index in children undergoing herniotomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kshithija S 
Designation  Junior Resident , Dept of Anaesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital Mumbai 
Address  Department of Anaesthesiology Lokmanya Tilak Municipal Medical College and General Hospital Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8904495567  
Fax    
Email  postkshithija95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anila Malde 
Designation  Professor and Head, Department of Anaesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Department of Anaesthesiology Lokmanya Tilak Municipal Medical College and General Hospital Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anila Malde 
Designation  Professor and Head, Department of Anaesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Department of Anaesthesiology Lokmanya Tilak Municipal Medical College and General Hospital Mumbai


MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical College 
Address  Lokmanya Tilak Municipal Medical College, Mumbai-400022 
Type of Sponsor  Government 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 Anila Malde  Lokmanya Tilak Municipal Medical College and General Hospital   Department of Anaesthesiology Lokmanya Tilak Municipal Medical College and General hospital Sion, Mumbai-400022, Maharashtra
Mumbai
MAHARASHTRA 
9821085730

dradmalde@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Tilak Municipal Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.all children undergoing elective herniotomy
2.ASA grade i,ii,iii
3.age more than 1 year and less than 6years 
 
ExclusionCriteria 
Details  1.children with mental retardation
2.children who are already on
a]anticonvulsants
b]sedatives
c]antihistaminics
d]anxiolytics
e]opioids
3. children with raised intracranial pressures
4.children with altered sensorium 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
to study the correlation between preoperative anxiety using modified Yale preoperative anxiety scale and depth of anaesthesia using bispectral index in children undergoing elective herniotomy under standardised anaesthesia protocol  1.baseline
2.loss of eyelash reflex[induction]
3.caudal block
4.before incision
5.after incision
6.every 5 mins till half hour
7. every half hour till end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
to study the correlation between modified Yale preoperative anxiety scale and bispectral index in children of different age categories  1.baseline
2.loss of eyelash reflex[induction]
3.caudal block
4.before incision
5.after incision
6.every 5 mins till half hour
7. every half hour till end of surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/08/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Anxiety is a state of worry caused by the anticipation of external or internal danger .Preoperative anxiety is a common occurrence among children undergoing surgery and can result in adverse physiological and psychological reactions. It is a general observation that highly anxious child has lower depth of anaesthesia.

The modified Yale preoperative anxiety scale remains the gold standard to evaluate preoperative anxiety in children. It is an observational measure consisting of 22 items divided into 5 categories: activity, vocalisation, emotional expressivity,state of arousal and use of parent. The score ranges from 5 to 22. It is usually used in children between the age of 2 to 6 years. Few studies have shown the validity of this scale in children less than 2 years also.

the bispectral index[BIS] is used to measure the effects of anaesthetics and sedatives on the brain and consciousness. It uses a complex mathematical algorithm based on descriptive EEG parameters from the frontal cortex to suggest various levels of sedation. A sensor placed on the patient’s forehead, sends raw EEG waveforms to the monitor, where they are analysed. The BIS value is a single number based on the previous 15seconds of EEG data and is updated frequently. This value ranges from 100[completely awake] to 0[isoelectric EEG]. For deeper sedation[general anaesthesia] aim is to target BIS from 40 to 60.
The depth of anaesthesia and thus the BIS values are dependant on many factors, mainly type of surgical stimulus, type of airway devices used[endotrachial tubes or supraglottic airway devices],sedatives and analgesics used, dosage of intravenous and inhalational anaestheitcs used, supplementary regional blocks. Provided these factors are kept constant, we can study the relationship between preoperative anxiety and [using MYPAS] and depth of anaesthesia[using BIS]

In our institute we have a fairly standardized protocol of general anaesthesia with supraglottic airway devices plus caudal epidural block for children undergoing herniotomy. This study aim to find out correlation between preoperative anxiety (using MYPAS) and depth of anaesthesia (using BIS). The hypothesis is that, more the child is anxious in the preoperative period, more the BIS value, i.e, lighter the plane of anaesthesia or in other words more the anaesthetic dose required for the maintenance of anaesthesia.

Anesthetic requirment may vary according to age also. So in this study, we will find out if similar correlation is there in all age groups. 
 
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