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Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

NCT ID: NCT01076790

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Anaesthesia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

Analgo-sedative, adjuvant of propofol anesthesia

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Precedex. CAS 113775476.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arvi Yli-Hankala

OTHER

Sponsor Role lead

Responsible Party

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Arvi Yli-Hankala

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arvi Yli-Hankala, MD

Role: STUDY_CHAIR

Tampere University Hospital

Arvi Yli-Hankala, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2009-014619-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Kotoe_01

Identifier Type: -

Identifier Source: org_study_id