Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079312
• Other study ID #: a001c
• Secondary ID: 2008-007968-42
• Status: Completed
• Phase: Phase 4
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: December 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Retrograde Cholangiopancreatography

Intervention

Device:
• infusion pump
anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level
• infusion 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.

Drug:
• propofol
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
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
Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)
• remifentanil hydrochlorid
Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Mazanikov M, Udd M, Kylänpää L, Lindström O, Aho P, Halttunen J, Färkkilä M, Pöyhiä R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	propofol and opioid consumption	total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure	one day
Primary	vital signs	heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration	one day
Primary	patient´s and endoscopist´s satisfaction	Likert scale 1-7	one day
Secondary	sedation level	sedation level assested with Ramsay,Gillham,OAA/S sedation scores	one day