Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli
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|ClinicalTrials.gov Identifier: NCT01076790|
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : October 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anaesthesia||Drug: Dexmedetomidine Drug: Saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|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|
Active Comparator: Dexmedetomidine
Analgo-sedative, adjuvant of propofol anesthesia
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.
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 [ 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01076790
|Tampere University Hospital|
|Tampere, Finland, 33521|
|Study Chair:||Arvi Yli-Hankala, MD||Tampere University Hospital|
|Principal Investigator:||Arvi Yli-Hankala, MD||Tampere University Hospital|