The Effect of Dexmedetomidine on Reactivity to Noxious Stimuli During Propofol-remifentanil Anaesthesia and Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Physiological reaction to noxious stimulus
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Dexmedetomidine
Analgo-sedative, adjuvant of propofol anesthesia
Intervention: Dexmedetomidine (Drug)
Dexmedetomidine
Analgo-sedative, adjuvant of propofol anesthesia
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Arvi Yli-Hankala
Professor
Tampere University Hospital