Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: Biliary Tract Diseases; Pancreatic Diseases
MeSH terms: Pancreatic Diseases; Biliary Tract Diseases
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): alfentanil; remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.; Remifentanil is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high dose opioid and low dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.It is administered in the form remifentanil hydrochloride and in adults is given as an intravenous infusion in doses ranging from 0.1 microgram per kilogram per minute to 0.5 (µg/kg)/min.
Other intervention name(s): Rapifen; Alfenta; Ultiva
Intervention MeSH terms: Remifentanil; Alfentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: patient-controlled sedation; propofol; alfentanil; remifentanil; endoscopic retrograde cholangiopancreatography