| CTRI Number |
CTRI/2024/07/071692 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of local anaesthetic into caudal space on blood glucose levels in children undergoing below umbilical surgery |
|
Scientific Title of Study
|
Effect of supplemental caudal analgesia on intraoperative blood glucose level in pediatric patients undergoing infraumbilical surgery |
| 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 Shivshankar R Tengli |
| Designation |
PG resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MSRamaiah Medical College
MSRIT Post
Bangalore
KARNATAKA
560054
India |
| Phone |
7019071190 |
| Fax |
|
| Email |
s19tengli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha C R |
| Designation |
Professor and Head |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MSRamaiah Medical College
MSRIT Post
Bangalore
KARNATAKA
560054
India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha C R |
| Designation |
Professor and Head |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MSRamaiah Medical College
MSRIT Post
Bangalore
KARNATAKA
560054
India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MSRamaiah medical college |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
New BEL Road, MSRIT Post, Bangalore, 560054 |
| Type of Sponsor |
Private 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 |
| Dr Geetha CR |
MS Ramaiah Medical College and Hospital |
Department of
Anaesthesiology,
Second floor, MS
Ramaiah Medical
College, New BEL
Road, Bangalore
560054
Bangalore
KARNATAKA |
9900482828
jageedha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College 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
|
| Type |
Name |
Details |
| Intervention |
Caudal block |
Caudal analgesia with general anaesthesia . A single shot of caudal analgesia with ropivacaine (0.2%) at 1ml/kg will be given 5 mins after intubation |
| Comparator Agent |
General anaesthesia |
General anaesthesia with fentanyl |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 1 – 6 years
American Society of Anesthesiologists physical status 1 and 2
Scheduled for elective infraumbilical surgeries
|
|
| ExclusionCriteria |
| Details |
Baseline blood sugar less than 70mg/dl
Patients allergic to local anesthetics
History of endocrine disorders
Patients on steroid supplementation
Any contraindication for caudal block Malformation of spine
Infection around puncture site Coagulation dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the blood glucose levels in children undergoing infraumbilical surgeries under general anaesthesia with and without caudal analgesia |
Baseline
30 minutes after start of surgery
60 minutes after start of surgery
30 minutes after end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative hemodynamic parameters between two groups
|
Hemodynamic parameters such as HR, Spo2, systolic blood pressure, diastolic blood pressure, mean arterial pressure, end tidal carbon dioxide will be monitored & values will be noted at 5mins, 10 mins, 15 mins, 20 mins, 30 mins, 40 mins, 50 mins, 60 mins, 70 mins, 80 mins, 90 mins, 100 mins, 110 mins, 120 mins.
|
|
|
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)
|
02/09/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Clinical study will be available as original article as publication in a journal
- For how long will this data be available start date provided 01-10-2027 and end date provided 01-10-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Surgery induces a neuroendocrine stress response resulting in changes of metabolic state and immune function. The stress response stimulates release of catecholamines and cortisol which have an anti-insulin action predisposing to increase plasma glucose levels. Hyperglycaemia increases the risk of hypoxic-ischemic brain or spinal cord damage, induces diuresis and subsequently dehydration and electrolyte imbalance. Pain is a major cause of stress in children and should be managed optimally in the perioperative period to reduce the adverse effects of stress response. Systemic analgesics and/or local anaesthetics in regional anaesthesia are administered for perioperative pain management which also blunts the surgical stress response. Caudal block is the most commonly employed technique of regional anaesthesia in children undergoing infraumbilical surgery for pain relief which may attenuate stress response and optimise blood glucose levels by inhibition of endogenous glucose production. Currently there is paucity of studies that have observed the effect of caudal analgesia on blood glucose level in children. Hence in our study we aim to compare the blood glucose level in children under general anaesthesia with and without caudal analgesia. We hypothesize that supplemental caudal analgesia with general anaesthesia may influence the intraoperative blood glucose levels. |