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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starvation | No Intervention | Fasting for 6-8 hours before the operation | |
| Water | Active Comparator | drink 400ml of water 2 hours before the operation |
|
| oral carbohydrate | Active Comparator | drink 400ml of solution 2 hours before the operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative carbohydrate solution | Dietary Supplement | water and solution will be given to patients to drink 2 hours before the operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric volume | Assessment of gastric volume by ultrasound | prior to anesthesia induction |
| 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 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emine Seyda Teloglu | Contact | +905394191544 | eteloglu@bezmialem.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem University | Recruiting | Istanbul | Fatih | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2023 | Jan 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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|
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 |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |