| CTRI Number |
CTRI/2024/12/078281 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prediction of success of caudal block |
|
Scientific Title of Study
|
Surgical pleth index to predict the success of caudal block in paediatric
patients under general anaesthesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchita Harchandani |
| Designation |
Junior resident |
| Affiliation |
KMC Manipal |
| Address |
Department of Anaesthesia
KMC Manipal
Manipal , Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8005784341 |
| Fax |
|
| Email |
ruchitaharchandani@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anitha Nileshwar |
| Designation |
Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of anaesthesia,KMC Manipal, Near tiger circle
Udupi
KARNATAKA
576104
India |
| Phone |
9880842121 |
| Fax |
|
| Email |
anitha.rshenoy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anitha Nileshwar |
| Designation |
Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of anaesthesia,KMC Manipal, Near tiger circle
Udupi
KARNATAKA
576104
India |
| Phone |
9880842121 |
| Fax |
|
| Email |
anithashenoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMC Manipal
Udupi, Karnataka, India
576104 |
|
|
Primary Sponsor
|
| Name |
Ruchita Harchandani |
| Address |
Department of anaesthesia
KMC Manipal
Udupi Karnataka India
576104 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Ruchita Harchandani |
Kasturba Hospital, Manipal |
Department of Anaesthesia
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8005784341
ruchitaharchandani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z408||Encounter for other prophylactic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologists (ASA) Physical Status Classification I and II patients
2.Age between 1-6 years undergoing elective infra umbilical surgery under general anaesthesia with supraglottic airway device and caudal analgesia
|
|
| ExclusionCriteria |
| Details |
1.Patients with pre-existing liver disorder
2.Patients with pre-existing renal disorder
3.Patients with pre-existing decompensated cardiac disorder
4.Patients with developmental delay
5.Patients with known organic brain disease
6.Patients with cerebral palsy
7.Patients with mental retardation
8.Patients with contraindications to caudal analgesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the reliability of SPI in predicting the success of caudal block in
anaesthetized children |
heart rate, Blood pressure,SPI will be monitored throughout the procedure and recorded at the time of skin incision
and an interval of 5 minutes after the time of incision till the beginning of skin closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the accuracy with which the anaesthesiologist will be able to diagnose the
success of caudal block intraoperatively |
Intaoperative assessment throughout the surgery, 30 mins after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2024 |
| Date of Study Completion (India) |
05/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Determining the success of caudal block under general anaesthesia could be difficult. A reliable assessment of the success of caudal block is critical to optimize analgesia in these patients. Conventionally success of caudal block under general anaesthesia is assessed through haemodynamic response to incision which could be unreliable. |