Evaluation of pharmacokinetic and –dynamic characteristics of norepinephrine for the augmentation of arterial blood pressure in healthy volunteers prior to and during general anesthesia
- Conditions
- Anesthesia
- Registration Number
- NL-OMON29148
- Lead Sponsor
- niversity Medical Center Groningen, dept of Anaesthesiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
?American Society of Anesthesiologists (ASA) Physical Status I or II
?No exclusion criterion is present
?Informed, and willing to give written informed consent.
?Refusal of the volunteer to participate
?Pregnancy
?Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic internal cardioverter defibrillator)
?A difference > 15 mmHg in measured systolic or diastolic blood pressure value (SBP, DBP) between the left and right upper arm, as determined by non-invasive cuff oscillometry during the screening visit.
?An increased risk of difficult mask ventilation or tracheal intubation, as judged by the anesthesiologist-researcher.
?Pulmonary disease
?Gastric or endocrinologic diseases
?End-stage liver or kidney failure
?Use of tricyclic antidepressive medication or MAO inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of this study will be the association between ABP and plasma concentrations of norepinephrine (awake state), and the association of ABP and plasma concentrations of norepinephrine during steady-state general anesthesia with propofol and remifentanil.
- Secondary Outcome Measures
Name Time Method -Evaluation of the effect of the interaction between propofol, remifentanil and norepinephrine on hemodynamics during general anesthesia.<br>-Evaluation of the effect(s) of endogenous norepinephrine plasma concentration on the relationship between administered dose (and plasma concentration) of norepinephrine and induced hemodynamic alteration(s).<br>-Evaluation of the Beloeil norepinephrine PKPKD model.<br>-Assessment of changes in mean systemic filling pressure prior to and after induction of general anesthesia, as assessed by arm stop-flow measurements by application of a rapidly inflated tourniquet. <br>-Evaluation of the dose-dependent effect of administered norepinephrine on plasma melatonin concentrations prior to and after induction of general anaesthesia.<br>