Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

Arvi Yli-Hankala

Status and phase: Completed; Phase 4

Conditions: Anaesthesia

Treatments: Drug: Saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01076790

2009-014619-11 (EudraCT Number)

Kotoe_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 1 patient group

Dexmedetomidine

Active Comparator group

Description:

Analgo-sedative, adjuvant of propofol anesthesia

Treatment:

Drug: Saline

Drug: Dexmedetomidine