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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 opioid

vital signs

Secondary outcome:

sedation levels

pain 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

Page last updated: August 23, 2015

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