Clinical trial NCT06289543: Preoperative Oral Carbohydrate on Gastric Emptying
Official title: The Effect of A Newly Formulated Preoperative Oral Carbohydrate Solution on Gastric Emptying, Postoperative Nausea and Vomiting and Stress Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vomit Aspiration
Anxiety
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Gastric volume
timeFrame: prior to anesthesia induction
Secondary outcomes:
measure: preoperative anxiety
timeFrame: before coming to the operating room, Scored between 20 and 80 points. A high score indicates high anxiety
measure: postoperative nausea and vomiting
timeFrame: up to postoperative 24 hours, numeric rank score is scored between 0 and 3 points
measure: thirst, hunger, fatigue, dry mouth
timeFrame: before drink (2 hous before surgery), prior to anesthesia induction, visual analog scale is scored between 0 and 10
measure: Postoperative Pain Score
timeFrame: up to postoperative 24 hours, visual analog scale is scored between 0 and 10
measure: postoperative insulin resistance
timeFrame: glucose, insulin and cortisol will be measured 2 hours before surgery(before drink), before induction and 2 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
state: Fatih
Study officials:
References: