| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
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Intervention / Comparator Agent
|
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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 |
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
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Blinding/Masking
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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 |
|
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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" |
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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
|
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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. |