Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Dexmedetomidine on Reactivity to Noxious Stimuli During Propofol-remifentanil Anaesthesia and Surgery

Conditions
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Anaesthesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Analgo-sedative, adjuvant of propofol anesthesia | Drug: Dexmedetomidine<br>* Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.<br>* Other names: Precedex. CAS 113775476.;Drug: Saline<br>* Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological reaction to noxious stimulus | Nociception-associated changes in EEG, EMG, Entropy Index values, BIS Index values, morphology of plethysmogram or ECG, heart rate, or hear rate variability. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nociception, Dexmedetomidine, Electroencephalogram, Electromyogram, Entropy Index, Bispectral Index, Electrocardiogram, Plethysmogram, Heart, Heart rate, Heart rate variability, Surgery