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Completed

NCT Number: NCT01079312

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit

Helsinki, Uusimaa, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

infusion pump

Device

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

Other names: -Braun AG, -an infusion pump

infusion pump for patient-controlled sedation

Device

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.

Other names: -Arcomed,Syramed AG,Switzerland, -infusion pump designed for self administration of the drugs

Propofol

Drug

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.

Other names: -Diprivan, -Recofol, -Fresofol

Fentanyl

Drug

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.

Other names: -fentanyl citrate, -fentanyl

sedative mixture

Drug

Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)

Other names: -Ultiva, -Diprivan

remifentanil hydrochlorid

Drug

Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)

Other names: -Ultiva

Primary outcomes

  1. propofol and opioid consumption

    Time frame: one day

    total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure

  2. vital signs

    Time frame: one day

    heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration

  3. patient´s and endoscopist´s satisfaction

    Time frame: one day

    Likert scale 1-7

Secondary outcomes

  1. sedation level

    Time frame: one day

    sedation level assested with Ramsay,Gillham,OAA/S sedation scores

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2010
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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