Preoperative Oral Carbohydrate on Gastric Emptying

The Effect of A Newly Formulated Preoperative Oral Carbohydrate Solution on Gastric Emptying, Postoperative Nausea and Vomiting and Stress Response

The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Vomit Aspiration
• Intervention / Treatment: Dietary supplement: Preoperative carbohydrate solution

Detailed Description

The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa.

109 patients who underwent elective laparoscopic cholecystectomy, aged 18-65 years, and ASA physical state 1-2 were included in the study. The patients were divided into 3 groups: Group A, who would not eat anything 6-8 hours before the operation, Group S, who drank 400 ml of water 2 hours before the operation, and Group K, which drank 400 ml preoperative oral carbohydrate solution (PreOKH) 2 hours before the operation. Before induction of anesthesia (T1), patients' antral gastric cross-sectional area (GKA) and gastric volume (GV) were evaluated by gastric ultrasound. The preoperative anxiety level of the patients was determined by the State-Trait Anxiety Inventory (STAl) before the operation (T1), and the symptoms affecting the preoperative patient comfort parameters (thirst, hunger, dry mouth, fatigue) were measured 2 hours before the operation (T0) and before the induction (T1) evaluated with the visual analog scale (VAS). Postoperative nausea and vomiting (PONV) and postoperative pain levels were recorded. Blood glucose, insulin, and cortisol levels of the patients were measured 2 hours before the operation (T0), before induction (T1), and postoperative 2nd hour (T3)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emine Seyda Teloglu; Phone Number: +905394191544; Email: eteloglu@bezmialem.edu.tr

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey
      • Recruiting
      • Bezmialem University
      • Contact: Kazim Karaaslan; Phone Number: +905055213865; Email: kazimkaraslan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between the ages of 18-65
• Elective laparoscopic cholecystectomy planned under general anesthesia
• American Society of Anesthesiologists (ASA) class I-II physical condition

Exclusion Criteria:

Patients with gastroesophageal reflux and gastrointestinal motility disorders diabetes mellitus Mental retardation, previous neurological disease symptoms (syncope, dementia, Alzheimer, etc.) Chronic alcoholism Difficult Intubation Patients with ASA physical status classes ≥III Patients with a body mass index of 35 and above History of Meniere and motion sickness Presence of previous history of postoperative nausea and vomiting Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Starvation; Fasting for 6-8 hours before the operation
Active Comparator: Water; drink 400ml of water 2 hours before the operation	Dietary supplement: Preoperative carbohydrate solution; water and solution will be given to patients to drink 2 hours before the operation; Other Names: Water
Active Comparator: oral carbohydrate; drink 400ml of solution 2 hours before the operation	Dietary supplement: Preoperative carbohydrate solution; water and solution will be given to patients to drink 2 hours before the operation; Other Names: Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric volume	Assessment of gastric volume by ultrasound	prior to anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative anxiety	preoperative anxiety will be assessed with the State-Trait Anxiety Inventory	before coming to the operating room, Scored between 20 and 80 points. A high score indicates high anxiety
postoperative nausea and vomiting	postoperative nausea and vomiting scores of the patients will be evaluated	up to postoperative 24 hours, numeric rank score is scored between 0 and 3 points
thirst, hunger, fatigue, dry mouth	thirst, hunger, fatigue, dry mouth will be evaluated with visual analog scale	before drink (2 hous before surgery), prior to anesthesia induction, visual analog scale is scored between 0 and 10
Postoperative Pain Score	Postoperative Pain Score will be evaluated with visual analog scale	up to postoperative 24 hours, visual analog scale is scored between 0 and 10
postoperative insulin resistance	Blood glucose mg/dL, Insulin milli-International unit/L, Cortisol µg/dL	glucose, insulin and cortisol will be measured 2 hours before surgery(before drink), before induction and 2 hours postoperatively

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 15, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BVU-ESTELOGLU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No