Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 9:50 AM
Study NCT ID:
NCT03952260
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2019-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of 1 Hour Clear Fluid Fasting Prior to Paediatric GA
Sponsor:
Ma Tai Jiun
Organization:
Study Overview
Official Title:
A Randomised Control Trial Comparing 6-4-1 Fasting Protocol Against Classical 6-4-2 Fasting Guideline for Paediatric Patients
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is aim to investigate the appropriate fasting time for clear fluid in paediatric patients who plan for elective minor surgery.
This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours.
It is important to determine the gastric residual volume for paediatric age group prior to elective minor surgery in order to determine whether the difference between 1 hour fasting and 2 hour fasting for clear fluid is significant.
This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours.
It is important to determine the gastric residual volume for paediatric age group prior to elective minor surgery in order to determine whether the difference between 1 hour fasting and 2 hour fasting for clear fluid is significant.
Detailed Description:
This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.
The research question is should investigator change fasting protocol for paediatric patients prior to operation.
The anaesthesia service is being studied. Participants are patients who are 5-16 years old are planned for elective minor surgery in ent, eye, dental surgery, general surgery and orthopaedics.
This study will be done in UMMC. 2 groups of patients will be recruit which consists of 50 patients each. Each of the group will be instructed to fast for clear fluid for 1 hour or 2 hours prior to surgery. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, patients anxiety level prior to and 1 hour post general anaesthesia will be assess. Also, parents of patients will complete a questionnaire after the surgery to assess parental satisfaction toward anaesthesia service.
The research question is should investigator change fasting protocol for paediatric patients prior to operation.
The anaesthesia service is being studied. Participants are patients who are 5-16 years old are planned for elective minor surgery in ent, eye, dental surgery, general surgery and orthopaedics.
This study will be done in UMMC. 2 groups of patients will be recruit which consists of 50 patients each. Each of the group will be instructed to fast for clear fluid for 1 hour or 2 hours prior to surgery. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, patients anxiety level prior to and 1 hour post general anaesthesia will be assess. Also, parents of patients will complete a questionnaire after the surgery to assess parental satisfaction toward anaesthesia service.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: