| CTRI Number |
CTRI/2024/02/062410 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the role of Perfusion Index As assessment tool In predicting Successful Caudal Block In Paediatric Patients with the help of pulse oximeter |
|
Scientific Title of Study
|
Evaluation Of Pulse Oximeter Perfusion Index As Assessment Tool In Predicting Successful Caudal Block In Paediatric Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Geetika |
| Designation |
Junior resident doctor |
| Affiliation |
Guru Gobind Singh Medical College and Hopital |
| Address |
Department of Anaesthesiology,Guru Gobind Singh Medical College and Hospital,Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8847373372 |
| Fax |
|
| Email |
bharal.ginni789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Amanjot Singh |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology,Guru Gobind Singh medical college and hospital ,Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9814921142 |
| Fax |
|
| Email |
amanjotrajpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amanjot Singh Rajpal |
| Designation |
Associate Professor |
| Affiliation |
Gobind Singh Medical College and Hospital |
| Address |
Dept. of Anaesthesia, GGSMCH,Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9814921142 |
| Fax |
|
| Email |
amanjotrajpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Guru Gobind Singh Medical college and Hospital,Faridkot |
|
|
Primary Sponsor
|
| Name |
Dr Amanjot Singh |
| Address |
Department of Anaesthesiology , GGSMCH,Faridkot |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Geetika |
Guru Gobind Singh medical college and hospital |
Department of Anaesthesiology,Guru Gobind Singh Medical College and Hospital
Faridkot
PUNJAB |
8847373372
bharal.ginni789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Gobind Singh Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Perfusion index |
To assess the efficacy of pulse oximeter perfusion index in predicting successful caudal block. This is being done during intraoperative time. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Paediatric patients aged 2 to 10 years belonging to ASA grade I & II
2. Elective infra umbilical surgeries |
|
| ExclusionCriteria |
| Details |
1.Children undergoing bilateral infra umblical surgeries.
2.Children with altered sacral,caudal anatomy and skeletal deformities.
3.Local infection at the site of block.
4.Children with renal or hepatic insufficiency.
5.Known allergy to study drugs.
6. History of developmental delay, neurological diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To monitor perfusion index(PI )trends after caudal block .
2. To study the role of perfusion index, haemodynamic variables in detecting onset of caudal block.
3. To establish the relationship between perfusion index and haemodynamic variables in detecting the onset and adequacy of caudal block. |
Outcome will be assessed at the end of study of 1.5 yrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the relationship between perfusion index and haemodynamic variables in detecting the onset and adequacy of caudal block. |
Outcome will be assessed at the end of study of 1.5 yrs. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Caudal block is one of the commonest regional techniques performed in children.It is usually performed under I.v. sedation which makes it difficult to assess the success and onset of the caudal block.So, there have been various methods to detect the success of the caudal block. Recently, perfusion index has been used to assess the success of caudal anaesthesia in adults. Perfusion index is non invasive technique that measures the peripheral perfusion and we will monitor the perfusion index trends after caudal block as well as we will study the role of perfusion index, haemodynamic variables in detecting onset and adequacy of caudal block. |