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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29148
Enrollment
36
Registered
2021-03-08
Start date
2021-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Anesthesia

Interventions

Phase 1: While the subject is awake, norepinephrine will be administered in a standardized step-up dosing scheme. Phase 2: After a wash-out phase, general anesthesia will be induced using a standardi

Sponsors

University Medical Center Groningen, dept of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- Evaluation of the effect of the interaction between propofol, remifentanil and norepinephrine on hemodynamics during general anesthesia. - 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). - Evaluation of the Beloeil norepinephrine PKPKD model. - 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. - Evaluation of the dose-dependent effect of administered norepinephrine on plasma melatonin concentrations prior to and after induction of general anaesthesia.

Contacts

Public ContactT.F. Buisman

Universitair Medisch Centrum Groningen

t.f.buisman@umcg.nl050 3611464

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)