Endoscopic Retrograde Cholangiopancreatography
Conditions
Keywords
ERCP, patient-controlled sedation, propofol, remifentanil, sedation level
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.
Interventions
DEVICEinfusion pump
anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level
DEVICEinfusion pump for patient-controlled sedation
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.
DRUGpropofol
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.
DRUGfentanyl
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.
DRUGsedative mixture
Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)
DRUGremifentanil hydrochlorid
Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| propofol and opioid consumption | one day | total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure |
| vital signs | one day | heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration |
| patient´s and endoscopist´s satisfaction | one day | Likert scale 1-7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sedation level | one day | sedation level assested with Ramsay,Gillham,OAA/S sedation scores |
Countries
Finland
Outcome results
None listed