Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli
The Effect of Dexmedetomidine on Reactivity to Noxious Stimuli During Propofol-remifentanil Anaesthesia and Surgery
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedOctober 9, 2013
October 1, 2013
1.3 years
February 25, 2010
October 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Dexmedetomidine
ACTIVE COMPARATORAnalgo-sedative, adjuvant of propofol anesthesia
Interventions
Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
Eligibility Criteria
You may qualify if:
- males or females giving informed consent
- age range 18-70 years
- elective surgery: laparoscopy, laparotomy, breast surgery
- general anaesthesia
- ASA classification 1 or 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arvi Yli-Hankalalead
Study Sites (1)
Tampere University Hospital
Tampere, 33521, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Arvi Yli-Hankala, MD
Tampere University Hospital
- PRINCIPAL INVESTIGATOR
Arvi Yli-Hankala, MD
Tampere University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2010
First Posted
February 26, 2010
Study Start
November 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
October 9, 2013
Record last verified: 2013-10