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Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Tampere University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01076790
First received: February 25, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

Dexmedetomidine acts at central nervous system (specifically: at locus caeruleus), providing sedative and analgesic effects. It is widely used in intensive care. Surgery-related interventions elicit arousal ('nociceptive') reactions. The effects of dexmedetomidine on the neurophysiological signs of arousal are studied in surgical patients. Brain waves, electrocardiogram, Entropy Index, Bispectral Index, and fingertip pulse waves are recorded and analyzed later on. The course of anaesthesia and surgery are recorded.


Condition Intervention Phase
Anaesthesia
 Drug: Dexmedetomidine
Drug: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Dexmedetomidine on Reactivity to Noxious Stimuli During Propofol-remifentanil Anaesthesia and Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Physiological reaction to noxious stimulus [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Nociception-associated changes in EEG, EMG, Entropy Index values, BIS Index values, morphology of plethysmogram or ECG, heart rate, or hear rate variability.


Estimated Enrollment: 44
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexmedetomidine
    Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
    Other Name: Precedex. CAS 113775476.
    Drug: Saline
    Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
Detailed Description:

The patients are randomized to receive either dexmedetomidine or saline infusion before and during anaesthesia (dexmedetomidine 0.1 mcg/kg within 10 minutes, thereafter 0.7 mcg/kg/h until 30 min after skin incision).

Multi-channel EEG, Entropy, BIS, multi-channel EMG, ECG, and plethysmogram are recorded on computer. Anaesthesia and surgery associated events are annotated on computer.

Time points of endotracheal intubation, skin incision, and course of surgery well be analyzed in detail. Additionally, tetanic stimulus of ulnar nerve will be applied for each patient, and reactions to the stimulus will be analyzed.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males or females giving informed consent
  • age range 18-70 years
  • elective surgery: laparoscopy, laparotomy, breast surgery
  • general anaesthesia
  • ASA classification 1 or 2

Exclusion Criteria:

  • pregnancy
  • body mass index 30.1 or more
  • diseases affecting CNS, autonomic nervous system, heart, heart rate, or circulation
  • chronic use of drugs affecting CNS, autonomic nervous system, heart, heart rate, or circulation; except antihypertensives, which are acceptable in this study
  • chronic use of clonidine
  • serious psychiatric disease or condition
  • overuse of alcohol
  • use of illicit drugs
  • unability of understand, read or use Finnish language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076790

Contacts
Contact: Arvi Yli-Hankala, MD +35833116111 arvi.yli-hankala@uta.fi
Contact: Ville Jäntti, MD +35833116111 ville.jantti@uta.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Arvi Yli-Hankala, MD     +35833116111     arvi.yli-hankala@uta.fi    
Contact: Ville Jäntti, MD     +35833116111     ville.jantti@uta.fi    
Sub-Investigator: Kotoe Kamata, MD            
Sub-Investigator: Maija Vainikka, BSc (med)            
Sub-Investigator: Antti Aho, MD            
Sub-Investigator: Leo-Pekka Lyytikäinen, MD            
Sub-Investigator: Pasi Puumala, MD            
Sub-Investigator: Mirja Tenhunen, MSc (eng)            
Sponsors and Collaborators
Tampere University Hospital
Investigators
Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
Principal Investigator: Arvi Yli-Hankala, MD Tampere University Hospital
  More Information

No publications provided

Responsible Party: Arvi Yli-Hankala / Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01076790     History of Changes
Other Study ID Numbers: Kotoe_01, 2009-014619-11
Study First Received: February 25, 2010
Last Updated: February 25, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:
Nociception
Dexmedetomidine
Electroencephalogram
Electromyogram
Entropy Index
Bispectral Index
 Electrocardiogram
Plethysmogram
Heart
Heart rate
Heart rate variability
Surgery

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 22, 2013