| CTRI Number |
CTRI/2019/01/016984 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
07/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to find out what will happen to blood glucose levels if glucose is added or not added to fluids given to chlildren below one year during operation |
|
Scientific Title of Study
|
Comparison of effect of Ringers lactate, with and without addition of dextrose, on intraoperativr blood glucose levels in infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Rajan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Amrita Institute of Medical Sciences
Kochi
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9447464652 |
| Fax |
04842802020 |
| Email |
sunilrajan@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Rajan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Amrita Institute of Medical Sciences
Kochi
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9447464652 |
| Fax |
04842802020 |
| Email |
sunilrajan@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushik Barua |
| Designation |
MD resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Amrita Institute of Medical Sciences
Kochi
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
8086028783 |
| Fax |
04842802020 |
| Email |
kaushikbarua13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences, Ponekkara PO, Kochi 682041, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences
Kochi |
| 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 Sunil Rajan |
Amrita Institute of Medical Sciences |
Department of Anaesthesiology
Ernakulam
KERALA |
9447464652
04842802020
sunilrajan@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q378||Unspecified cleft palate with bilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dextrose |
1% dextrose was added to Ringer lactate in one group and only Ringer lactate was used in other group |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Forty infants of American Society of Anesthesiologists (ASA) physical status 1 undergoing cheiloplasty and palatoplasty were recruited into the study |
|
| ExclusionCriteria |
| Details |
Infants of diabetic mothers and those with endocrine disorders and anticipated difficult airway were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the present study is to evaluate the effect of addition of 1% dextrose to intra-operative maintenance fluids (Ringer’s lactate) on blood glucose levels in infants undergoing facial cleft surgeries. |
After induction, then hourly intraoperatively for 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives include assessment of development of hypoglycemia or hyperglycemia in these patients when intraoperative fluids were used with and without added dextrose. |
After induction, then hourly intraoperatively for 2 hours |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/01/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
One group receives Ringer lactate intraoperatively and the other group receives Ringer lactate with 1% dextrose intraoperatively. Incidence of any hypoglycemia or hyperglycemia is noted in both groups.
|