Preoperative Oral Carbohydrate on Gastric Emptying
- Conditions
- AnxietyVomit Aspiration
- Interventions
- Dietary Supplement: Preoperative carbohydrate solution
- Registration Number
- NCT06289543
- Lead Sponsor
- Bezmialem Vakif University
- Brief 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.
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Between the ages of 18-65
- Elective laparoscopic cholecystectomy planned under general anesthesia
- American Society of Anesthesiologists (ASA) class I-II physical condition
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oral carbohydrate Preoperative carbohydrate solution drink 400ml of solution 2 hours before the operation Water Preoperative carbohydrate solution drink 400ml of water 2 hours before the operation
- Primary Outcome Measures
Name Time Method Gastric volume prior to anesthesia induction Assessment of gastric volume by ultrasound
- Secondary Outcome Measures
Name Time Method thirst, hunger, fatigue, dry mouth before drink (2 hous before surgery), prior to anesthesia induction, visual analog scale is scored between 0 and 10 thirst, hunger, fatigue, dry mouth will be evaluated with visual analog scale
Postoperative Pain Score up to postoperative 24 hours, visual analog scale is scored between 0 and 10 Postoperative Pain Score will be evaluated with visual analog scale
postoperative insulin resistance glucose, insulin and cortisol will be measured 2 hours before surgery(before drink), before induction and 2 hours postoperatively Blood glucose mg/dL, Insulin milli-International unit/L, Cortisol µg/dL
postoperative nausea and vomiting up to postoperative 24 hours, numeric rank score is scored between 0 and 3 points postoperative nausea and vomiting scores of the patients will be evaluated
preoperative anxiety before coming to the operating room, Scored between 20 and 80 points. A high score indicates high anxiety preoperative anxiety will be assessed with the State-Trait Anxiety Inventory
Trial Locations
- Locations (1)
Bezmialem University
🇹🇷Istanbul, Fatih, Turkey