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

NCT ID: NCT04875845

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-04-30

Brief Summary

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.

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.

Conditions

Gastric Volume; Ultrasonography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

6-hours fasting gastric volume

gastric volume measured after 6-hours fasting

Fasting for elective surgery

Intervention Type: BEHAVIORAL

6-hours and 8-hours fasting before elective surgery

8-hours fasting gastric volume

gastric volume measured after 8-hours fasting

Fasting for elective surgery

Intervention Type: BEHAVIORAL

6-hours and 8-hours fasting before elective surgery

Interventions

Fasting for elective surgery

6-hours and 8-hours fasting before elective surgery

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Raden Besthadi Sukmono

Anesthesiologist, Regional Anesthesia Consultant, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raden B Sukmono

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

RSUPN Cipto Mangunkusumo

Jakarta, , Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

GVES

Identifier Type: -

Identifier Source: org_study_id