| CTRI Number |
CTRI/2020/09/027511 [Registered on: 01/09/2020] Trial Registered Prospectively |
| Last Modified On: |
30/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
It is a study to see changes in Perfusion Index while giving general anaesthesia to children undergoing elective surgery and to compare the results with Bispectral Index |
|
Scientific Title of Study
|
Correlation of Perfusion Index with Bispectral Index for depth of anaesthesia in children undergoing elective surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Kumar |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416336901 |
| Fax |
|
| Email |
pk.pgims@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Upmanyoo |
| Designation |
post graduate trainee |
| Affiliation |
Pt. B.D. Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8348407514 |
| Fax |
|
| Email |
pooja.upmanyoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Upmanyoo |
| Designation |
post graduate trainee |
| Affiliation |
Pt. B.D. Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak
HARYANA
124001
India |
| Phone |
8348407514 |
| Fax |
|
| Email |
pooja.upmanyoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.B.D. Sharma, PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Pt.B.D. Sharma, PGIMS, Rohtak |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja Upmanyoo |
Pt. B. D. Sharma PGIMS |
Department of Anaesthesiology and Critical Care, first floor, MS Office building, PGIMS
Rohtak
HARYANA |
8348407514
pooja.upmanyoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients belonging to American Society of Anaesthesiologists(ASA) physical status I or II scheduled for elective surgery requiring general anaesthesia in supine position will be enrolled in this study |
|
| ExclusionCriteria |
| Details |
Patients having peripheral circulatory disorder, dyshemoglobinemia(methemoglobinemia, sickle cell anaemia, thalassemia, anaemia), neurological disorders, receiving treatment with antiepileptic medications or stimulants, pre-existing lung or cardiac disease, airway abnormalities, artificial nails, dark pigmentation over fingers or patients having contraindication to the planned anaesthesia technique will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in anaesthetic requirement with correlation to Perfusion Index |
baseline, 2 minutes after induction, at airway manipulation, at 5 and 10 minutes following induction of general anaesthesia, at cessation , at eye opening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Perfusion Index with Bispectral Index |
at baseline, 2 minutes after induction, on airway manipulation, 5 minutes, 10 minutes after induction, cessation of anaesthetic, eye opening |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/09/2020 |
| 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="0"
Months="8"
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
|
Perfusion Index is the ratio of pulsatile blood flow signal as percentage of non pulsatile blood flow signal. It is a non invasive, reliable and indirect representation of the peripheral perfusion and circulatory status. During general anaesthesia, peripheral vasodialation is a well known side effect and it induces changes in the amplitude of the pulse plethysmograph waveform which can be recorded using Masimo Radical-7 SET monitor as Perfusion Index and it can be compared with Bispectral Index which has been established as a method of measurement of depth of anaesthesia for induction, maintainence as well as recovery phase. We hypothesized that the Perfusion Index would increase with the induction of general anaesthesia and decrease with emergence in children. Using PI in comparison to BIS may help in developing a useful tool for intraoperative anaesthesia monitoring and the assessment of anaesthetic depth. Although there are limited studies in literature comparing PI and BIS, so we have planned to conduct this study to compare trends of PI in correlation to BIS for depth of anaesthesia and to see changes in PI with time during general anaesthesia. The study is a prospective and observational study with a total of 50 , ASA I or II paediatric patients aged between 2-12 years of either sex scheduled for elective surgery requiring general anaesthesia in supine position. |