Clinical trial NCT03952260: Feasibility of 1 Hour Clear Fluid Fasting Prior to Paediatric GA
Official title: A Randomised Control Trial Comparing 6-4-1 Fasting Protocol Against Classical 6-4-2 Fasting Guideline for Paediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Residual Volume
Keywords: Clear fluid fasting
residual gastric volume
paediatric anaesthesia
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 56
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia
timeFrame: Prior to induction of general anaesthesia
Secondary outcomes:
measure: Anxiety level of patients by short version of(mYPAS)modified Yale Preoperative Anxiety Scale after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia
timeFrame: Prior to induction of general anaesthesia and 1 hour post anaesthesia
measure: Parental satisfaction by questionnaires after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia
timeFrame: 2 hours to 24 hours post anaesthesia
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
affiliation: University of Malaya
name: Ma Tai Jiun, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Ina Ismiarti binti Shariffuddin, Ass. Prof
role: STUDY_CHAIR
References: