The Effect of A Newly Formulated Preoperative Oral Carbohydrate Solution on Gastric Emptying, Postoperative Nausea and Vomiting and Stress Response
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Gastric volume
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Starvation
Fasting for 6-8 hours before the operation
Water
drink 400ml of water 2 hours before the operation
Intervention: Preoperative carbohydrate solution (Dietary Supplement)
oral carbohydrate
drink 400ml of solution 2 hours before the operation
Intervention: Preoperative carbohydrate solution (Dietary Supplement)
Outcomes
Primary Outcomes
Gastric volume
Time Frame: prior to anesthesia induction
Assessment of gastric volume by ultrasound
Secondary Outcomes
- thirst, hunger, fatigue, dry mouth(before drink (2 hous before surgery), prior to anesthesia induction, visual analog scale is scored between 0 and 10)
- Postoperative Pain Score(up to postoperative 24 hours, visual analog scale is scored between 0 and 10)
- postoperative insulin resistance(glucose, insulin and cortisol will be measured 2 hours before surgery(before drink), before induction and 2 hours postoperatively)
- postoperative nausea and vomiting(up to postoperative 24 hours, numeric rank score is scored between 0 and 3 points)
- preoperative anxiety(before coming to the operating room, Scored between 20 and 80 points. A high score indicates high anxiety)
Investigators
Emine Şeyda Teloğlu
Physician, Department of Anesthesiology
Bezmialem Vakif University