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

NCT ID: NCT01350037

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Biliary Tract Diseases Pancreatic Diseases

Keywords

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patient-controlled sedation propofol alfentanil remifentanil endoscopic retrograde cholangiopancreatography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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remifentanil

sedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 ml

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

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.

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

Group Type ACTIVE_COMPARATOR

alfentanil

Intervention Type DRUG

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.

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

Group Type ACTIVE_COMPARATOR

alfentanil

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Rapifen Alfenta Ultiva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maxim Mazanikov

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reino Pöyhiä, MD,PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care

Maxim Mazanikov, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care

Martti Färkkilä, MD,Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology

Leena Kylänpää, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Jorma Halttunen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Outi Lindström, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Harri Mustonen, DSc

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital, Department of Surgery

Marianne Udd, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Locations

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Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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2009-012398-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

a002c

Identifier Type: -

Identifier Source: org_study_id