Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- infusion pump
- Conditions
- Endoscopic Retrograde Cholangiopancreatography
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- vital signs
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.
Detailed Description
80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.
Investigators
Maxim Mazanikov
M.D.
Helsinki University Central Hospital
Eligibility Criteria
Inclusion Criteria
- •elective ERCP-patients
Exclusion Criteria
- •allergy to propofol or opioid;
- •ASA-class (American Society of Anaesthesiology) greater than 3;
- •inability to co-operate;
- •drugs abuse.
Arms & Interventions
Propofol infusion
Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
Intervention: infusion pump
Propofol infusion
Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
Intervention: propofol
Propofol infusion
Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml
Intervention: fentanyl
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
Intervention: infusion pump for patient-controlled sedation
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
Intervention: propofol
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
Intervention: sedative mixture
Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
Intervention: remifentanil hydrochlorid
Outcomes
Primary Outcomes
vital signs
Time Frame: one day
heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration
patient´s and endoscopist´s satisfaction
Time Frame: one day
Likert scale 1-7
propofol and opioid consumption
Time Frame: one day
total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure
Secondary Outcomes
- sedation level(one day)