| CTRI Number |
CTRI/2020/10/028554 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Does glucose need to be given when children receiving caudal analgesia during surgery? |
|
Scientific Title of Study
|
Does the addition of caudal analgesia warrant dextrose supplementation in pediatric abdominal surgery? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrLakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences ad Research Centre |
| Address |
Tower 6 Floor 1
Department of Anaesthesia
Amrita institute of Medical Sciences
Kochi
Amrita Lane
Edapally
Kochi
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrLakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences ad Research Centre |
| Address |
Tower 6 Floor 1
Department of Anaesthesia
Amrita institute of Medical Sciences
Kochi
Amrita Lane
Edapally
Kochi
Kerala
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShruthy babu |
| Designation |
Senior Resident Anaesthesia |
| Affiliation |
Amrita Institute of Medical Sciences ad Research Centre |
| Address |
Tower 6 Floor 1
Department of Anaesthesia
Amrita institute of Medical Sciences
Kochi
Amrita Lane
Edapally
Kochi
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9633596685 |
| Fax |
914842852020 |
| Email |
sruthibabu90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Tower 6, floor 1
AIMS Kochi |
| 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 |
| DrLakshmi Kumar |
Amrita Institute of Medical Sciences |
Tower 6 Floor 1
Department of Anaesthesia
Kochi
Ernakulam
KERALA |
9496211333
914842852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
No dextrose supplemented during abdominal surgery with caudal analgesia with 0.2 % ropivacaine. Blood sugars monitored half hourly during surgery |
Blood sugar at baseline R0
at 30 mins R 30, R60, R 90 and R final. |
| Comparator Agent |
Standard 1% dextrose supplementation at Holliday and Segar formula rate during surgery with caudal analgesia with 0.2% ropivacaine |
Blood sugars at baseline R0, at 30 mins R 30, R 60, R 90 and R final. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 6 months - 6 years
2. Surgery ≥ 1hour
3. Fasting for 6 hours for solid food and formula feeds, 4 hours for breast milk, 2 hours for glucose-containing fluids.
|
|
| ExclusionCriteria |
| Details |
1. ASA physical status ≥2
2. Patients diagnosed with endocrine disorders/ on steroid supplementation
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood sugars meausured half hourly during surgery with and without supplemental glucose in children receiving caudal analgesia undergoing abdominal surgery |
1. Baseline R0
2. 30 minutes R 30
3. 60 minutes R 60
4. 90 mintes R 90
5. End of surgery R final. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic changes , hear rate and blood pressure at the same time points.
Opioid consumption during surgery |
Baseline R0
2. 30 minutes R 30
3. 60 minutes R 60
4. 90 mintes R 90
5. End of surgery R final. |
|
|
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)
|
30/10/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Regional anesthesia obtunds tress responses to surgery and anesthesia. We propose to evaluate the blood sugar profiles amongst children undergoing abdominal surgery with caudal analgesia with and without dextrose supplementation with a view to document the safety of withholding dextrose containing solutions in children undergoing surgery.
|