| CTRI Number |
CTRI/2020/07/026345 [Registered on: 03/07/2020] Trial Registered Prospectively |
| Last Modified On: |
02/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ringer Lactate v/s ringer lactate with 2% dextrose on intraoperative blood glucose level in paediatric age group |
|
Scientific Title of Study
|
Effect of ringer lactate v/s ringer lactate with 2% dextrose on intraoperative blood glucose level in paediatric surgery cases with respect to preoperative fasting hours: A randomized double blind interventional study at SMS Hospital during 2019-2021 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alaka Purohit |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia
Second floor, SMS Medical College and Hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8003399995 |
| Fax |
|
| Email |
purohitalaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alaka Purohit |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia
Second floor, SMS Medical College and Hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8003399995 |
| Fax |
|
| Email |
purohitalaka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindoora Sumithran |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia
Second Floor, SMS medical college and hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9620734430 |
| Fax |
|
| Email |
sindoora.sumithran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, SMS Medical College, JLN marg, Jaipur PIN Code: 302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia SMS Medical College |
| Address |
Department of Anaesthesia, SMS Medical College, JLN marg, Jaipur |
| 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 |
| Dr Alaka Purohit |
SMS Medical College and Hospital, Jaipur |
Department of Anaesthesia Second Floor, SMS Medical College and Hospital, Jaipur
Jaipur
RAJASTHAN |
8003399995
purohitalaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Ringer Lactate |
IV infusion of Ringer Lactate via peripheral IV line at 10ml/kg body weight |
| Comparator Agent |
Ringer Lactate with 2% Dextrose |
IV infusion of Ringer Lactate with 2% dextrose via peripheral IV line at 10ml/kg body weight |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II Patients
Patients willing to give written informed consent.
Weight 10 kg to 30 kg.
Paediatric patients undergoing surgeries like herniotomy, orcidopexy, eye surgeries, circumsicion etc under general anaesthesia (Duration : 50min± 20mins) |
|
| ExclusionCriteria |
| Details |
Ex premature infants, children with cardiac, neurological, endocrine, or metabolic diseases.
Patients on fluid therapy. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the difference in variation in Blood Glucose level from baseline to intra operative period every 30 mins interval till end of surgery.
|
Baseline to intra operative period every 30 mins interval till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the vitals intra operatively such as HR, SPO2, RR , pre induction and post operative blood ketone body levels and side effects if any.
|
Baseline to intra operative period every 30 mins interval till end of surgery |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/07/2020 |
| 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="3"
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)?
|
|
Brief Summary
|
To compare effect of Ringer Lactate v/s Ringer Lactate with 2% dextrose on intraoperative blood glucose levels in paediatric surgeries with respect to preoperative fasting hours |