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NCT Number: NCT01076790

Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

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.

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Key information

Conditions

Anaesthesia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.

Other names: Precedex. CAS 113775476.

Saline

Drug

Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Arvi Yli-Hankala

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 26, 2010
Registry last updated
Oct 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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