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Semaglutide and Preoperative Residual Gastric Volumes 90

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06263595 ist eine beobachtungsstudie zur Untersuchung von Pulmonale Aspiration und hat den Status offene rekrutierung. Die Studie startete am 31. Mai 2024 und soll 90 Teilnehmer aufnehmen. Durchgeführt von Universität von Calgary ist der Abschluss für 31. Juli 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 25. März 2025 aktualisiert.
Kurzbeschreibung
Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by rece...Mehr anzeigen
Offizieller Titel

Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide

Erkrankungen
Pulmonale Aspiration
Weitere Studien-IDs
  • REB23-1754
NCT-Nummer
NCT06263595
Studienbeginn (tatsächlich)
2024-05-31
Zuletzt aktualisiert
2025-03-25
Studienende (vorauss.)
2025-07-31
Geplante Rekrutierung
90
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
GLP-1 Agonist Group
Intervention: elective surgical patients taking GLP-1 receptor agonists
gastric antral sonography
Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.
Non GLP-1 Agonist Group
Intervention: elective surgical patients not taking GLP-1 receptor agonists
gastric antral sonography
Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Number of participants presenting with a full stomach
Full stomach defined as either clear fluid \> 1.5ml/kg or solid content found with point-of-care gastric antral sonography.
Measured in the preoperative holding area
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Number of occurrences requiring change in anesthetic management plan
Changes in plan include those from laryngeal mask airway to more advanced endotracheal tube with rapid sequence induction and intubation or spinal anesthetic without sedation to administration of a general anesthetic.
From time of preoperative ultrasound in holding area to anesthesia induction in operating room
Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume
Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume
Measured in the preoperative holding area
Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration
Explore if GLP-1 receptor agonist impacts gastric emptying different in patients administering for Type II diabetes mellitus or weight management
Measured in the preoperative holding area
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • all elective surgical patients (> 18 years of age)
  • followed institutional fasting protocol for surgery
  • patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
  • patients not taking GLP-1 receptor agonist (N =45)

  • confounding delayed gastric emptying due to pregnancy
  • previous esophageal or gastric operation
  • etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
  • on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)
University of Calgary logoUniversität von Calgary215 aktive klinische Studien zum Erkunden
Alberta Health services logoAlberta Health services
Verantwortliche Partei
Joanna Moser, Hauptprüfer, Clinical Assistant Professor, University of Calgary
Zentrale Studienkontakte
Kontakt: Joanna J Moser, MD, PhD, 403-956-3883, [email protected]
1 Studienstandorte in 1 Ländern

Alberta

South Health Campus, Calgary, Alberta, T3M 1M4, Canada
Joanna J Moser, MD, PhD, Kontakt, 403-956-3883, [email protected]
Offene Rekrutierung