Preoperative Oral Carbohydrate on Gastric Emptying

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289543
• Other study ID #: BVU-ESTELOGLU
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: February 2024
• Source: Bezmialem Vakif University
• Contact: Emine Seyda Teloglu
• Phone: +905394191544
• Email: eteloglu[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 15, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety

Intervention

Dietary Supplement:
• Preoperative carbohydrate solution
water and solution will be given to patients to drink 2 hours before the operation

Locations

Country	Name	City	State
Turkey	Bezmialem University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric volume	Assessment of gastric volume by ultrasound	prior to anesthesia induction
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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