Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Information source: Helsinki University Central Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Biliary Tract Diseases; Pancreatic Diseases
Intervention: alfentanil (Drug); remifentanil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Helsinki University Central Hospital Official(s) and/or principal investigator(s): Reino Pöyhiä, MD,PhD, Study Director, Affiliation: Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care Maxim Mazanikov, MD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care Martti Färkkilä, MD,Professor, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology Leena Kylänpää, MD,PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery Jorma Halttunen, MD,PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery Outi Lindström, MD,PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery Harri Mustonen, DSc, Principal Investigator, Affiliation: Helsinki University Central Hospital, Department of Surgery Marianne Udd, MD,PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Summary
Self-administration of propofol and opioid mixture by the patient him- or herself
(patient-controlled sedation, PCS) could be successful alternative to the
anesthesiologists-managed deep sedation during endoscopic retrograde
cholangiopancreatography (ERCP). However, it is not known which opioid would be the most
suitable for PCS. The aim of this double-blind study was to compare remifentanil and
alfentanil in PCS during ERCP.
Clinical Details
Official title: Alfentanil vs Remifentanil in Patient-controlled Sedation During ERCP.A Randomized Double-blind Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: consumption of propofol and opioidvital signs
Secondary outcome: sedation levelspain intensity patient´s and endoscopist´s satisfaction with sedation incidence of nausea
Detailed description:
Deep sedation with propofol has been suggested necessary for successful performance of
endoscopic retrograde cholangiopancreatography (ERCP).Airway obstruction, hypoventilation
and hypoxemia occurs in deeply sedated patients with a high incidence of 12-30%.As a result
of frequent hypoxemia events, deep sedation is associated with increased morbidity and
mortality. Careful monitoring of vital signs and involving of anesthesia-trained personal are
recommended for deeply sedated patients. Self-administration of propofol by the patient him-
or herself (patient-controlled sedation, PCS)could be a safer way to use propofol without
the presence of an anesthesiologist. In comparison to the anesthesiologists managed deep
sedation the main advantages of PCS are reduced consumption of anesthetics and faster
recovery. A combination of propofol and different opioids is widely used for PCS however, it
is not known which opioid would be the most suitable one. Remifentanil is a potent opioid
with ultra short duration of action and usually administered as a constant infusion. The
elimination half-life of alfentanil is 8-32 minutes being about 3 times longer, than that of
remifentanil. Both opioids have been evaluated previously in PCS but comparative studies are
lacking. This study was carried out in order to compare remifentanil and alfentanil in PCS
during ERCP in terms of propofol consumption, sedation levels, endoscopist´s and patient's
satisfaction. The investigators also sought information about frequency of sedation related
complications associated with the different opioids.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- elective ERCP patients
Exclusion Criteria:
- allergy to propofol or opioid analgesics, drug addiction, inability to co-operate,
ASA class greater than 3, or patient's refusal.
Locations and Contacts
Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit, Helsinki, Uusimaa 00029, Finland
Additional Information
Starting date: June 2009
Last updated: July 4, 2012
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