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

NCT04875845 | Completed

• 1 other identifier: GVES
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Volume; Ultrasonography

Keywords

Gastric volume; preoperative fasting; ultrasonography.

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

6-hours fasting gastric volume

gastric volume measured after 6-hours fasting

Behavioral: Fasting for elective surgery

8-hours fasting gastric volume

gastric volume measured after 8-hours fasting

Behavioral: Fasting for elective surgery

Interventions

Fasting for elective surgery BEHAVIORAL

6-hours and 8-hours fasting before elective surgery

6-hours fasting gastric volume; 8-hours fasting gastric volume

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• ASA 1-2 who would undergo non-digestive elective surgery in Cipto Mangunkusumo Hospital
• Body mass index between 20-30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Cipto Mangunkusumo

Jakarta, 01430, Indonesia

Location

MeSH Terms

Interventions

Elective Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Raden B Sukmono

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Regional Anesthesia Consultant, Assistant Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 6, 2021
• Study Start: January 1, 2019
• Primary Completion: February 28, 2019
• Study Completion: April 30, 2019
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)