Evaluation of pharmacokinetic and *dynamic characteristics of norepinephrine for the augmentation of arterial blood pressure in healthy volunteers prior to and during general anesthesia

Completed

• Conditions: general anaesthesia; narcose; sleep medication

• Registration Number: NL-OMON51910
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- American Society of Anesthesiologists (ASA) Physical Status I or II
- No exclusion criterion is present
- Informed, and willing to give written informed consent.

Exclusion Criteria

- 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
<p>- The relationship between plasma concentrations of norepinephrine and<br /><br>hemodynamics in terms of heart rate, cardiac index (CI), stroke volume index<br /><br>(SVI), and systolic, diastolic and mean arterial blood pressure (SAP, DAP, MAP,<br /><br>respectively) in awake circumstances.<br /><br>- The relationship between plasma concentrations of norepinephrine and<br /><br>hemodynamics in terms of heart rate, cardiac index (CI), stroke volume index<br /><br>(SVI), and systolic, diastolic and mean arterial blood pressure (SAP, DAP, MAP,<br /><br>respectively) during standardized general anesthesia using propofol and<br /><br>remifentanil administration.<br /><br>- The hemodynamic effects will be related to drug concentrations using PKPD<br /><br>analysis / modelling. </p><br>