Clinical trial NCT01350037: Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Alfentanil vs Remifentanil in Patient-controlled Sedation During ERCP.A Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biliary Tract Diseases
Pancreatic Diseases
Keywords: patient-controlled sedation
propofol
alfentanil
remifentanil
endoscopic retrograde cholangiopancreatography
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: consumption of propofol and opioid
timeFrame: one day
measure: vital signs
timeFrame: one day
Secondary outcomes:
measure: sedation levels
timeFrame: one day
measure: pain intensity
timeFrame: one day
measure: patient´s and endoscopist´s satisfaction with sedation
timeFrame: one day
measure: incidence of nausea
timeFrame: one day
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care
name: Reino Pöyhiä, MD,PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
name: Maxim Mazanikov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology
name: Martti Färkkilä, MD,Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Leena Kylänpää, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Jorma Halttunen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Outi Lindström, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital, Department of Surgery
name: Harri Mustonen, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Marianne Udd, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: