Feasibility of 1 Hour Clear Fluid Fasting Prior to Paediatric GA

Ma Tai Jiun

Status: Completed

Conditions: Gastric Residual Volume

Treatments: Other: Fasting time for clear fluid prior to anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03952260

2019211-7120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 5-16 years old
• elective open minor surgery in ent, eye, dental surgery, general surgery and orthopaedics

Exclusion criteria

• Gastro-oesophageal reflux (GORD)
• renal failure
• severe cerebral palsy
• some enteropathies
• oesophageal strictures
• achalasia
• diabetes mellitus with gastroparesis
• surgical contra-indications
• Emergency cases
• patients that were already intubated

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Fasting clear fluid for 1 hour prior to anaesthesia

Active Comparator group

Description:

Fasting clear fluid for 1 hour prior to anaesthesia

Treatment:

Other: Fasting time for clear fluid prior to anaesthesia

Fasting clear fluid for 2 hours prior to anaesthesia

No Intervention group

Description:

Fasting clear fluid for 2 hours prior to anaesthesia