Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) Agonist Prior to Anesthesia

Официальное название

Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor Agonist Prior to Anesthesia

Обзор

The purpose of this study is to determine if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and symptoms of nausea, vomiting, retching, abdominal bloating, and abdominal pain are present on the day of surgery, to see if there is any variability between preoperative gastric ultrasound assessment and volume of gastric contents visualized on upper endoscopy, to determine time of gastric emptying by serial Gastric ultrasonography (GUS) scans every 2 hours in subjects who presented with an initial at-risk scan, to determine the choice of anesthesia used based on preoperative GUS results, to determine if there were any adverse events recorded in this study group, to determine if duration of GLP-1 RA therapy has an association with residual gastric content (RGC). and to determine if dosing of GLP-1 RA has an association with RGC.

Вмешательства

• Другое GLP-1 RA users with prolonged fasting instructions
  NPO for solids: 24 hours prior to procedure, clear liquid diet (CLD) for 24 hours with last intake of clears no less than 2 hours prior to a procedure.GLP-1 RA will not be held prior to surgery and usual dosing schedule will be followed prior to procedure.
• Другое GLP-1 RA users with standard NPO instructions
  NPO after midnight prior to procedure; Minimum solid fasting duration of 8 hours for solids and 2 hours for liquids. Last dose of GLP-1 RA no less than 7 days prior to procedure.

Первичные конечные точки

• Number of participants that show prevalence of increased RGC determined using preoperative GUS [Срок оценки: prior to procedure ( within 2 hours before procedure)]

Вторичные конечные точки (3)

• Number of participants that show thirst as assessed by the VAS [Срок оценки: prior to procedure ( within 2 hours before procedure)]
• Number of participants that show hunger as assessed by the VAS [Срок оценки: prior to procedure ( within 2 hours before procedure)]
• Number of participants that show anxiety as assessed by the VAS [Срок оценки: prior to procedure ( within 2 hours before procedure)]

Критерии участия

Критерии включения

• Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
• Undergoing upper endoscopy only - no colonoscopy due to prep

Критерии исключения

• Previous gastric resection or bypass
• Gastric band in situ
• Previous fundoplication
• Large hiatal hernia
• Pregnant patients
• Recent trauma
• Inability to turn to the right lateral decubitus position.
• Patients on erythromycin, metoclopramide, domperidone, opioids.
• Gastroparesis previous

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06654219 · HSC-MS-24-0940

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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