Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maxim Mazanikov, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01350037
First received: May 5, 2011
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Biliary Tract Diseases
Pancreatic Diseases
Drug: alfentanil
Drug: remifentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Alfentanil vs Remifentanil in Patient-controlled Sedation During ERCP.A Randomized Double-blind Study

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • consumption of propofol and opioid [ Time Frame: one day ] [ Designated as safety issue: No ]
  • vital signs [ Time Frame: one day ] [ Designated as safety issue: Yes ]
    Heart rate (HR), electrocardiogram (ECG), breathing rate, peripheral oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2) constant monitoring. Noninvasive blood pressure (NIBP)measuring at 5 min intervals.


Secondary Outcome Measures:
  • sedation levels [ Time Frame: one day ] [ Designated as safety issue: No ]
    Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score

  • pain intensity [ Time Frame: one day ] [ Designated as safety issue: No ]
    Numeric range scale

  • patient´s and endoscopist´s satisfaction with sedation [ Time Frame: one day ] [ Designated as safety issue: No ]
  • incidence of nausea [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: remifentanil
sedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 ml
Drug: remifentanil
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 Name: Ultiva
Active Comparator: alfentanil 0.04 mg/ml
sedative mixture for PCS consisting of propofol10 mg/ml 20 ml,alfentanil 0.5 mg/ml 2 ml, NaCL 9 mg/ml 3 ml
Drug: alfentanil
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.
Other Names:
  • Rapifen
  • Alfenta
Active Comparator: alfentanil 0.08 mg/ml
sedative mixture for PCS consisting of propofol 10 mg/ml 20 ml, alfentanil 0.5 mg/ml 4 ml,NaCl 9mg/ml 1ml
Drug: alfentanil
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.
Other Names:
  • Rapifen
  • Alfenta

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01350037

Locations
Finland
Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Study Director: Reino Pöyhiä, MD,PhD Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care
Principal Investigator: Maxim Mazanikov, MD Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
Principal Investigator: Martti Färkkilä, MD,Professor Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology
Principal Investigator: Leena Kylänpää, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Principal Investigator: Jorma Halttunen, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Principal Investigator: Outi Lindström, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Principal Investigator: Harri Mustonen, DSc Helsinki University Central Hospital, Department of Surgery
Principal Investigator: Marianne Udd, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
  More Information

No publications provided

Responsible Party: Maxim Mazanikov, M.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01350037     History of Changes
Other Study ID Numbers: a002c, 2009-012398-36
Study First Received: May 5, 2011
Last Updated: July 4, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
patient-controlled sedation
propofol
alfentanil
remifentanil
endoscopic retrograde cholangiopancreatography

Additional relevant MeSH terms:
Pancreatic Diseases
Biliary Tract Diseases
Digestive System Diseases
Remifentanil
Alfentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 22, 2014