Comparison of Gastric Volume After 6-hour and 8-hour Fasting in Patient Scheduled for Elective Surgery

Preoperative fasting was a common practice to decrease perioperative aspiration risk. Duration of fasting was proportional to gastric volume. Short fasting duration may increase aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration and hypoglycemia.

The objective of this study was to analyze gastric volume after 6-hour and 8-hour duration of fasting after consumption of solid meal on patients scheduled for elective surgery.

This was a cohort study recruiting 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Before fasting, all subjects consumed standard Cipto Mangunkusumo meal and was later assessed for gastric volume using ultrasound at 6 and 8 hour after meal was consumed.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Gastric Volume
• Intervention / Treatment: Behavioral: Fasting for elective surgery

Detailed Description

Background. Preoperative fasting was a common practice to decrease perioperative aspiration risk. Duration of fasting was proportional to gastric volume. Short fasting duration may increase aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration and hypoglycemia. The protocols of 8 hours preoperative fasting was recommended by American Society of Anesthesiologist (ASA) after a full meal. The meal recognized by ASA to make this guidelines were Western diet that contains more fat. South East Asian (SEA) standard solid meal mainly contains rice and less protein and fats. We hypothesized 6-hours compared with 8-hours fasting was sufficient to provide ideal gastric volume for preoperative fasting after SEA standard solid meal. The objective of this study was to analyze gastric volume after 6-hour and 8-hour of fasting after consumption of SEA standard solid meal on patients scheduled for elective surgery.

Methods This was a cohort study recruiting 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Inclusion criteria were age between 18 to 60 years old, have no nutritional status disorder, and ASA physical status of 1 or 2. The exclusion criteria were patients with diabetes mellitus, pregnancy, abdominal distention, history of dyspepsia, and intestinal motility disturbances.

Subjects agreed to take part in the research, will be initial examined for obtaining demographic data: age, weight and height, type of surgery to be performed, and preoperative examinations. The subject will start 8 hours of fasting before the surgical planning time. Before fasting, the subjects were given Cipto Mangunkusumo Hospital food standardized nutritional levels. Subjects were given 1 hour to consume the food. Six hours after the standard meal is consumed, an ultrasound examination will be performed in the right lateral decubitus position to obtain ultrasound imaging of the antrum. After that, the subject continued fasting until 8 hours after meal and ultrasound examination was performed using the same technique to obtain images of ultrasound imaging of the antrum. Imaging pictures are taken at the time relaxation of the antrum, between two contractions. The results of this imaging are stored and assessments of antrum craniocaudal (CC) and anteroposterior (AP) diameters were performed by research assistants who don't know when the image was taken. These measurements were used to calculate Cross Sectional Area (CSA) using the formula of CSA=(π×CC×AP)/4. The Gastric Volume (GV) was then calculated with the formula GV=27.0+(14.6×CSA)-(1.28×age).

The primary data obtained was the result of repeated examinations. The analysis was adjusted using the Bonferonni correction factor. Categorical data was analyzed using the McNemar test. The results of data processing are displayed in tabular form. The gastric volume was grouped into sufficient and insufficient with a border value of 1.5ml/kg.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 01430
    • RSUPN Cipto Mangunkusumo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This was a cohort study for 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital

Description

Inclusion Criteria:

• The inclusion criteria were patients aged 18-60 years
• ASA 1-2 who would undergo non-digestive elective surgery in Cipto Mangunkusumo Hospital
• Body mass index between 20-30 kg/m2

Exclusion Criteria:

• patient who is not willing to enter the study
• patients with diabetes mellitus
• pregnancy
• abdominal distension
• intestinal motility disorders
• history of dyspepsia
• patients who do not receive the standard Cipto Mangunkusumo Hospital diet
• changes of the surgery schedule in which the patient is unable to do 8-hours fasting before surgery
• the patient who has an emergency in the perioperative period
• the patient was unable to consume the standard food provided

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
6-hours fasting gastric volume; gastric volume measured after 6-hours fasting	Behavioral: Fasting for elective surgery; 6-hours and 8-hours fasting before elective surgery
8-hours fasting gastric volume; gastric volume measured after 8-hours fasting	Behavioral: Fasting for elective surgery; 6-hours and 8-hours fasting before elective surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Volume 6-hours	Gastric volume measured with ultrasound after 6-hours of preoperative fasting	After 6-hours of preoperative fasting
Gastric Volume 8-hours	Gastric volume measured with ultrasound after 8-hours of preoperative fasting	After 8-hours of preoperative fasting

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: preoperative fasting; Gastric volume; ultrasonography.
• Other Study ID Numbers: GVES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No