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Dose-sparing Balanced Propofol Sedation in Colonoscopy
Sponsor: University of Split, School of Medicine
Summary
This randomized controlled trial compared two balanced propofol analgosedation strategies in adults undergoing elective colonoscopy. Participants were randomized to either a standard-dose protocol using an initial propofol dose of 1.0 mg/kg or a structured dose-sparing protocol using an initial propofol dose of 0.5 mg/kg. Both protocols included midazolam and fentanyl. The standard-dose protocol was anesthesiologist-guided, whereas the dose-sparing protocol was administered by a gastroenterologist trained in advanced life support and airway management, with an anesthesia technician present and an anesthesiologist immediately available if required. The primary outcomes were patient satisfaction and clinically relevant respiratory adverse events, with apnea lasting more than 30 seconds as the principal respiratory safety endpoint. Secondary outcomes included propofol exposure, recovery, procedural performance, cardiovascular adverse events, depth of sedation and nociception-related indices, and endoscopist satisfaction.
Official title: Dose-sparing Balanced Propofol Analgosedation for Colonoscopy: a Randomized Controlled Trial of a Structured Sedation Protocol
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2022-06-05
Completion Date
2024-02-08
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Standard-dose balanced propofol analgosedation
Intravenous balanced analgosedation with midazolam, fentanyl, and propofol. Midazolam was administered at 0.05 mg/kg, up to a maximum dose of 5 mg. Fentanyl 0.001 mg/kg was administered 3 minutes later, followed by an initial propofol bolus of 1.0 mg/kg at minute 5. Additional propofol boluses of 10-30 mg were administered according to clinical need and patient response during colonoscopy. Sedation and monitoring were guided by an anaesthesiologist with an anaesthesia technician present.
Dose-sparing balanced propofol analgosedation
Intravenous balanced analgosedation with midazolam, fentanyl, and propofol. Midazolam was administered at 0.05 mg/kg, up to a maximum dose of 5 mg. Fentanyl 0.001 mg/kg was administered 3 minutes later, followed by an initial propofol bolus of 0.5 mg/kg at minute 5. Additional propofol boluses of 10-30 mg were administered according to clinical need and patient response during colonoscopy. Sedation and monitoring were guided by a gastroenterologist trained in advanced life support and airway management, with an anaesthesia technician present and an anaesthesiologist immediately available if required.
Locations (2)
Polyclinic J&J Medici
Split, Split-Dalmatia County, Croatia
University Hospital of Split
Split, Split-Dalmatia County, Croatia