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

5. mai 2021 oppdatert 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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

37

Kontakter og plasseringer

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Studiesteder

      • Jakarta, Indonesia, 01430
        • RSUPN Cipto Mangunkusumo

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gastric Volume 6-hours
Tidsramme: 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
Tidsramme: After 8-hours of preoperative fasting
Gastric volume measured with ultrasound after 8-hours of preoperative fasting
After 8-hours of preoperative fasting

Samarbeidspartnere og etterforskere

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2019

Primær fullføring (Faktiske)

28. februar 2019

Studiet fullført (Faktiske)

30. april 2019

Datoer for studieregistrering

Først innsendt

21. april 2021

Først innsendt som oppfylte QC-kriteriene

2. mai 2021

Først lagt ut (Faktiske)

6. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2021

Sist bekreftet

1. mai 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GVES

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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