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Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01076790
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : October 9, 2013
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Anaesthesia Drug: Dexmedetomidine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Dexmedetomidine on Reactivity to Noxious Stimuli During Propofol-remifentanil Anaesthesia and Surgery
Study Start Date : November 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Dexmedetomidine
Analgo-sedative, adjuvant of propofol anesthesia
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.

Primary Outcome Measures :
  1. Physiological reaction to noxious stimulus [ Time Frame: 30 minutes ]
    Nociception-associated changes in EEG, EMG, Entropy Index values, BIS Index values, morphology of plethysmogram or ECG, heart rate, or hear rate variability.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01076790

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Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Arvi Yli-Hankala
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Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
Principal Investigator: Arvi Yli-Hankala, MD Tampere University Hospital
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Responsible Party: Arvi Yli-Hankala, Professor, Tampere University Hospital Identifier: NCT01076790    
Other Study ID Numbers: Kotoe_01
2009-014619-11 ( EudraCT Number )
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Keywords provided by Arvi Yli-Hankala, Tampere University Hospital:
Entropy Index
Bispectral Index
Heart rate
Heart rate variability
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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