Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2025-12-17 @ 5:09 PM
Study NCT ID:
NCT04875845
Status:
None
Last Update Posted:
2021-05-10 00:00:00
First Post:
2021-04-21 00:00:00
Brief Title:
Comparison of Gastric Volume After 6-hour and 8-hour Fasting in Patient Scheduled for Elective Surgery
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Comparison of Gastric Volume After 6-hour and 8-hour Fasting in Patient Scheduled for Elective Surgery
Status:
None
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 dont know when the image was taken These measurements were used to calculate Cross Sectional Area CSA using the formula of CSAπCCAP4 The Gastric Volume GV was then calculated with the formula GV270146CSA-128age
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 15mlkg
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 dont know when the image was taken These measurements were used to calculate Cross Sectional Area CSA using the formula of CSAπCCAP4 The Gastric Volume GV was then calculated with the formula GV270146CSA-128age
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 15mlkg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None