A Phase 4 interventional study of Dexmedetomidine and Saline in Anaesthesia, sponsored by Arvi Yli-Hankala. Completed at 1 site in Finland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-10-09.
Sponsored by Arvi Yli-Hankala · Phase 4, Interventional, and Basic science
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.
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.
Arvi Yli-Hankala is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Analgo-sedative, adjuvant of propofol anesthesia
Drug: Dexmedetomidine · Drug: Saline
Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
Also known as: Precedex. CAS 113775476.
Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
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.
Time frame: 30 minutes
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Arvi Yli-Hankala