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

NCT01350037 | Completed Phase 4

• 2 other identifiers: a002c2009-012398-36
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Diseases; Pancreatic Diseases

Keywords

patient-controlled sedation; propofol; alfentanil; remifentanil; endoscopic retrograde cholangiopancreatography

Outcome Measures

Primary Outcomes (2)

• consumption of propofol and opioid

  one day

• 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.

  one day

Secondary Outcomes (4)

• sedation levels

  one day

• pain intensity

  one day

• patient´s and endoscopist´s satisfaction with sedation

  one day

• incidence of nausea

  one day

Study Arms (3)

remifentanil

ACTIVE COMPARATOR

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

Drug: remifentanil

alfentanil 0.04 mg/ml

ACTIVE COMPARATOR

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 0.08 mg/ml

ACTIVE COMPARATOR

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

Interventions

alfentanil 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.

Also known as: Rapifen, Alfenta

alfentanil 0.04 mg/ml; alfentanil 0.08 mg/ml

remifentanil 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.

Also known as: Ultiva

remifentanil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective ERCP patients

You may not qualify if:

• allergy to propofol or opioid analgesics, drug addiction, inability to co-operate, ASA class greater than 3, or patient's refusal.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Biliary Tract Diseases; Pancreatic Diseases

Interventions

Alfentanil; Remifentanil

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Reino Pöyhiä, MD,PhD

  Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 9, 2011
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

FI (1)