Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01076790

Enrollment

Registered

2010-02-26

Start date

2009-11-30

Completion date

2011-03-31

Last updated

2013-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Keywords

Nociception, Dexmedetomidine, Electroencephalogram, Electromyogram, Entropy Index, Bispectral Index, Electrocardiogram, Plethysmogram, Heart, Heart rate, Heart rate variability, Surgery

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.

Interventions

DRUGDexmedetomidine

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

DRUGSaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Physiological reaction to noxious stimulus	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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026