The effect of dexmedetomidine on reactivity of a propofol-anaesthetized patient - Dexmedetomidiini ja reaktiivisuus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014619-11-FI

Enrollment

Registered

2009-08-19

Start date

2009-10-09

Completion date

Unknown

Last updated

2015-01-06

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

Conditions

Surgical patients scheduled for elective surgery under general anaesthesia. Otherwise in stable medical condition (ASA status 1 or 2). MedDRA version: 12.0 Level: LLT Classification code 10023696 Term: Laparotomy MedDRA version: 12.0 Level: LLT Classification code 10023697 Term: Laparotomy & drainage MedDRA version: 12.0 Level: LLT Classification code 10051777 Term: Staging laparotomy MedDRA version: 12.0 Level: LLT Classification code 10053361 Term: Explorative laparotomy MedDRA version: 1

Interventions

Trade Name: Propofol-Lipuro 10 mg/ml Product Name: Propofol-Lipuro 10 mg/ml Pharmaceutical Form: Intravenous infusion Trade Name: Precedex Product Name: Precedex Pharmaceutical Form: Intravenous infu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 - 70 years. Non-pregnant females or males. Scheduled laparoscopic, laparotomic or breast surgery during general anaesthesia. Adequate physical condition (ASA classification status 1 or 2). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy. BMI over 30,0 kg / m2. Disease or medication (except anti-hypertensives) affecting central nervous system, autonomic nervous system, circulation, or heart. Severe mental disease. Overuse of alcohol. Use of illegal drugs. Inability to read, hear or understand Finnish language.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of dexmedetomidine on behaviour of electroencephalogram (EEG), electromyogram, electrocardiogram, plethysmographic pulse wave, and skin conductance during adequate propofol anaesthesia and noxious stimuli. Noxious stimuli mean endotracheal intubation, tetanic stimulus of ulnar nerve, and skin incision.;Secondary Objective: To study the effect of dexmedetomidine on EEG-based indices of anaesthetic state (Entropy and BIS) during propofol anaesthesia and noxious stimuli.;Primary end point(s): The alterations in measured physiological signs in association with noxious stimuli.	—

Measure

Time frame

Main Objective: To study the effect of dexmedetomidine on behaviour of electroencephalogram (EEG), electromyogram, electrocardiogram, plethysmographic pulse wave, and skin conductance during adequate propofol anaesthesia and noxious stimuli. Noxious stimuli mean endotracheal intubation, tetanic stimulus of ulnar nerve, and skin incision.;Secondary Objective: To study the effect of dexmedetomidine on EEG-based indices of anaesthetic state (Entropy and BIS) during propofol anaesthesia and noxious stimuli.;Primary end point(s): The alterations in measured physiological signs in association with noxious stimuli.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026