Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Primary Purpose
Biliary Tract Diseases, Pancreatic Diseases
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
alfentanil
remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Diseases focused on measuring patient-controlled sedation, propofol, alfentanil, remifentanil, endoscopic retrograde cholangiopancreatography
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.
Sites / Locations
- Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
remifentanil
alfentanil 0.04 mg/ml
alfentanil 0.08 mg/ml
Arm Description
sedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 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
sedative mixture for PCS consisting of propofol 10 mg/ml 20 ml, alfentanil 0.5 mg/ml 4 ml,NaCl 9mg/ml 1ml
Outcomes
Primary Outcome Measures
consumption of propofol and opioid
vital signs
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
Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score
pain intensity
Numeric range scale
patient´s and endoscopist´s satisfaction with sedation
incidence of nausea
Full Information
NCT ID
NCT01350037
First Posted
May 5, 2011
Last Updated
July 4, 2012
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01350037
Brief Title
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
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Diseases, Pancreatic Diseases
Keywords
patient-controlled sedation, propofol, alfentanil, remifentanil, endoscopic retrograde cholangiopancreatography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remifentanil
Arm Type
Active Comparator
Arm Description
sedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 ml
Arm Title
alfentanil 0.04 mg/ml
Arm Type
Active Comparator
Arm Description
sedative mixture for PCS consisting of propofol10 mg/ml 20 ml,alfentanil 0.5 mg/ml 2 ml, NaCL 9 mg/ml 3 ml
Arm Title
alfentanil 0.08 mg/ml
Arm Type
Active Comparator
Arm Description
sedative mixture for PCS consisting of propofol 10 mg/ml 20 ml, alfentanil 0.5 mg/ml 4 ml,NaCl 9mg/ml 1ml
Intervention Type
Drug
Intervention Name(s)
alfentanil
Other Intervention Name(s)
Rapifen, Alfenta
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
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.
Primary Outcome Measure Information:
Title
consumption of propofol and opioid
Time Frame
one day
Title
vital signs
Description
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.
Time Frame
one day
Secondary Outcome Measure Information:
Title
sedation levels
Description
Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score
Time Frame
one day
Title
pain intensity
Description
Numeric range scale
Time Frame
one day
Title
patient´s and endoscopist´s satisfaction with sedation
Time Frame
one day
Title
incidence of nausea
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reino Pöyhiä, MD,PhD
Organizational Affiliation
Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maxim Mazanikov, MD
Organizational Affiliation
Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martti Färkkilä, MD,Professor
Organizational Affiliation
Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leena Kylänpää, MD,PhD
Organizational Affiliation
Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorma Halttunen, MD,PhD
Organizational Affiliation
Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Outi Lindström, MD,PhD
Organizational Affiliation
Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harri Mustonen, DSc
Organizational Affiliation
Helsinki University Central Hospital, Department of Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianne Udd, MD,PhD
Organizational Affiliation
Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
We'll reach out to this number within 24 hrs