| CTRI Number |
CTRI/2023/09/057732 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Water and 5 percent dextrose administration in preoperative period] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of ultrasound in children to look for volume of fluid remaining in the stomach after orally allowing either clear water or glucose water before surgery |
|
Scientific Title of Study
|
Ultrasound Guided Assessment Of Gastric Volumes In Pediatric Patients Receiving Dextrose Water Versus Plain Water Preoperatively: A Randomized Controlled Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aikta Gupta |
| Designation |
Specialist -Grade1, Paediatric Anaesthesia |
| Affiliation |
Chacha Nehru Balchikitsalaya |
| Address |
2nd Floor,OT, Department of Paediatric Anaesthesia,Geeta Colony, Delhi
East
DELHI
110031
India |
| Phone |
9643308230 |
| Fax |
|
| Email |
aiktab@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aikta Gupta |
| Designation |
Specialist -Grade1, Paediatric Anaesthesia |
| Affiliation |
Chacha Nehru Balchikitsalaya |
| Address |
2nd Floor,OT, Department of Paediatric Anaesthesia,Geeta Colony, Delhi
DELHI
110031
India |
| Phone |
9643308230 |
| Fax |
|
| Email |
aiktab@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vrinda Chauhan |
| Designation |
Fellow Paediatric Anaesthesia |
| Affiliation |
Chacha Nehru Balchikitsalaya |
| Address |
2nd Floor,OT, Department of Paediatric Anaesthesia,Geeta Colony, Delhi
East
DELHI
110031
India |
| Phone |
8894949368 |
| Fax |
|
| Email |
vrindachauhan24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chacha Nehru Balchikitsalaya,Geeta Colony, Delhi |
|
|
Primary Sponsor
|
| Name |
NOT SPONSORED |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAikta Gupta |
Chacha Nehru Balchikitsalaya, Geeta Colony Delhi |
2nd floor, Preoperative room, Department of Anesthesia
East
DELHI |
9643308230
aiktab@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Chacha Nehru Balchikitsalaya, Delhi |
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 |
| Comparator Agent |
PLAIN WATER |
Oral administration of PLAIN WATER preoperatively two hours before surgery to pediatric patients and looking for the residual gastric volumes using ultrasound after 2 hours of giving these fluids |
| Intervention |
5 percent DEXTROSE WATER |
Oral administration of 5 percent dextrose preoperatively two hours before surgery to pediatric patients and looking for the residual gastric volumes using ultrasound after 2 hours of giving these fluids |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5 to 12 years undergoing elective surgery with ASA physical status grade 1 or 2 and children posted for surgery after 11 am
|
|
| ExclusionCriteria |
| Details |
Children with any gastrointestinal disease, hiatus hernia
Children being treated with medications affecting gastrointestinal motility like antidiarrheal medications, day care surgery patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasound guided cross sectional area of the antrum & the gastric volumes in both the groups at zero hours and two hours in patients receiving five percent dextrose water versus plain water |
AT ZERO HOUR BEFORE GIVING FLUID AND AT TWO HOURS OF GIVING FLUIDS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effects of allowing clear fluids on rate of post operative nausea vomiting & thirst |
Till 2 hours in postoperatively |
|
|
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)
|
25/09/2023 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
Gastric ultrasound is a non invasive and reliable bed side tool that can be used to assess the residual gastric volumes in patients undergoing surgery to check the fasting status. Adhering to the fasting guidelines clear fluids can be allowed 2 hours before surgery to avoid prolonged fasting times in patients. In this study we plan to do ultrasound guided assessment of residual gastric volumes after 2 hours of giving clear water or 5 % dextrose water to the pediatric patients in the preoperatively. Children aged between 5-12 years of age will be recruited. Randomization into two groups will be done. The cross sectional area of antrum can be calculated using ultrasound by using the maximum anteroposterior and maximum craniocaudal diameter.The gastric volume will be calculated then using this antral cross sectional area.The ultrasound will be performed at 2 time points at zero hours before giving fluids to confirm the fasting status and before surgery after 2 hours of giving fluids. Induction of anesthesia will be done as per the institutional protocols. After the surgery child will be observed in the postoperative area to look for any post operative nausea vomiting or feeling of any thirst and discharged to ward after the criteria of discharge from postanaesthesia care unit is met. |