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

5 maj 2021 uppdaterad av: Raden Besthadi Sukmono, Indonesia University

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

37

Kontakter och platser

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Studieorter

      • Jakarta, Indonesien, 01430
        • RSUPN Cipto Mangunkusumo

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
6-hours fasting gastric volume
gastric volume measured after 6-hours fasting
6-hours and 8-hours fasting before elective surgery
8-hours fasting gastric volume
gastric volume measured after 8-hours fasting
6-hours and 8-hours fasting before elective surgery

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Gastric Volume 6-hours
Tidsram: After 6-hours of preoperative fasting
Gastric volume measured with ultrasound after 6-hours of preoperative fasting
After 6-hours of preoperative fasting
Gastric Volume 8-hours
Tidsram: After 8-hours of preoperative fasting
Gastric volume measured with ultrasound after 8-hours of preoperative fasting
After 8-hours of preoperative fasting

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2019

Primärt slutförande (Faktisk)

28 februari 2019

Avslutad studie (Faktisk)

30 april 2019

Studieregistreringsdatum

Först inskickad

21 april 2021

Först inskickad som uppfyllde QC-kriterierna

2 maj 2021

Första postat (Faktisk)

6 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 maj 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 maj 2021

Senast verifierad

1 maj 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • GVES

Plan för individuella deltagardata (IPD)

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