The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers (RemiAnes 1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00886106
First received: April 21, 2009
Last updated: November 17, 2009
Last verified: November 2009
  Purpose

Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.

Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.

Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.


Condition Intervention Phase
Hyperalgesia
Drug: Remifentanil
Drug: Midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Area of pin prick hyperalgesia [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain immediately after injection [ Time Frame: 0-15 min ] [ Designated as safety issue: No ]
  • Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN) [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • Heat pain threshold within the area of mechanical hyperalgesia [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 30 and 59 min after infusion of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: June 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Remifentanil
Drug: Remifentanil
Remifentanil (Ultiva®; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to circa 0.7 µg kg-1 min-1
Active Comparator: 2
Midazolam
Drug: Midazolam
Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied intravenously as active placebo at a dose of 15 µg kg-1 min-1 over 5 minutes to mimic typical central nervous side effects of remifentanil

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women, aged between 19 and 40 years
  • Body mass index between 15th and 85th percentile
  • Normal findings in the medical history and physical examination
  • Drug free for 1 week prior to the study day

Exclusion Criteria:

  • Regular use of medication especially analgesics
  • Abuse of alcoholic beverages, drug abuse
  • History of asthma
  • Participation in a clinical trial in the 2 weeks preceding the study
  • Symptoms of a clinically relevant illness in the 2 weeks before the first study day
  • Resting systolic blood pressure > 135 mmHg or diastolic blood pressure > 85 mmHg
  • Acute skin diseases like sunburn on the relevant areas or skin lesions
  • Pregnancy or breast feeding
  • Regular consumption of very spicy (capsaicin containing) food
  • Allergy against any medication used in the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886106

Contacts
Contact: Michael Andreae, MD +436769677181 michael@andreae.org
Contact: Stephan Stellnberger, MD +436507333189 stephan.stellnberger@meduniwien.ac.at

Locations
Austria
Department of Anaesthesia, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Michael Andreae, MD    +436769677181    michael@andreae.org   
Contact: Stephan Stellnberger, MD    +436507333189    stephan.stellnberger@meduniwien.ac.at   
Principal Investigator: Astrid Chiari, MD         
Sub-Investigator: Burkhard Gustorff, MD         
Sub-Investigator: Michael H Andreae, MD         
Sub-Investigator: Stephan Stellnberger, MD         
Sub-Investigator: Hanna Opelt, MD         
Sub-Investigator: Juergen Sandkuehler, MD, PHD         
Sub-Investigator: Ruth Drdla, PHD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Chair: Burkhard Gustorff, MD Medical University of Vienna
  More Information

Additional Information:
No publications provided

Responsible Party: Professor Burkhard Gustorff, Medical University of Vienna, Dept. Anaesthesia
ClinicalTrials.gov Identifier: NCT00886106     History of Changes
Other Study ID Numbers: RemiAnes 1
Study First Received: April 21, 2009
Last Updated: November 17, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Capsaicin
Remifentanil
Hyperalgesia

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Capsaicin
Remifentanil
Midazolam
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses
Adjuvants, Anesthesia
Central Nervous System Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014