Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: Endoscopic Retrograde Cholangiopancreatography
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): infusion pump; infusion pump for patient-controlled sedation; propofol; fentanyl; sedative mixture; remifentanil hydrochlorid
Intervention type(s): Device; Device; Drug; Drug; Drug; Drug
Intervention description(s): anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level; self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.; Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.; Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.; Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml); Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)
Other intervention name(s): -Braun AG; -an infusion pump; -Arcomed,Syramed AG,Switzerland; -infusion pump designed for self administration of the drugs; -Diprivan; -Recofol; -Fresofol; -fentanyl citrate; -fentanyl; -Ultiva; -Diprivan; -Ultiva
Intervention MeSH terms: Fentanyl; Remifentanil; Propofol; Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERCP; patient-controlled sedation; propofol; remifentanil; sedation level