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Preoperative Oral Carbohydrate on Gastric Emptying

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06289543
Enrollment
120
Registered
2024-03-04
Start date
2023-01-01
Completion date
2024-04-15
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Vomit Aspiration

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)

Interventions

DIETARY_SUPPLEMENTPreoperative carbohydrate solution

water and solution will be given to patients to drink 2 hours before the operation

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Gastric volumeprior to anesthesia inductionAssessment of gastric volume by ultrasound

Secondary

MeasureTime frameDescription
preoperative anxietybefore coming to the operating room, Scored between 20 and 80 points. A high score indicates high anxietypreoperative anxiety will be assessed with the State-Trait Anxiety Inventory
postoperative nausea and vomitingup to postoperative 24 hours, numeric rank score is scored between 0 and 3 pointspostoperative nausea and vomiting scores of the patients will be evaluated
thirst, hunger, fatigue, dry mouthbefore drink (2 hous before surgery), prior to anesthesia induction, visual analog scale is scored between 0 and 10thirst, hunger, fatigue, dry mouth will be evaluated with visual analog scale
Postoperative Pain Scoreup to postoperative 24 hours, visual analog scale is scored between 0 and 10Postoperative Pain Score will be evaluated with visual analog scale
postoperative insulin resistanceglucose, insulin and cortisol will be measured 2 hours before surgery(before drink), before induction and 2 hours postoperativelyBlood glucose mg/dL, Insulin milli-International unit/L, Cortisol µg/dL

Countries

Turkey (Türkiye)

Contacts

Primary ContactEmine Seyda Teloglu
eteloglu@bezmialem.edu.tr+905394191544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026