Pharmacokinetic and Pharmacodynamic Modelling of Norepinephrine in Patients Under Target Controlled Infusions (TCI) for Anaesthesia

NCT03454204 | Completed

• 2 other identifiers: K170902J2017-A02671-52
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, administration of norepinephrine diluted at 5 µg/ml bolus or continuous infusion is common during sympatholysis hypotension of TCI following the elimination of hypovolemia or anesthetic overdosage. Continued intravenous administration must meet hemodynamic goals within a narrow time frame. Depending on the intensity of hypotension the dosage is variable. It is adjusted in real time while it is excessive or insufficient at times. Therefore, the development of modeling should predict the kinetic and hemodynamic effects based on dosage and individual.

Conditions

Neurosurgery; Intervention

Outcome Measures

Primary Outcomes (1)

• PLASMATIC DOSAGES

  Relationship between exposure and the effect (desired-effectiveness or undesirable-toxicity) of norepinephrine during hypotension induced by anaesthetic drugs in a pharmacokinetic model (PLASMATIC DOSAGES) and pharmacodynamic model (HEMODYNAMIC EFFECTS MODELISED)

  1 day

Study Arms (1)

Pharmacokinetic

Establish a pharmacokinetic relationship between plasma concentration and the effect of norepinephrine in patients under concentration-target intravenous anesthesia by identifying significant covariates during general anesthesia.

Other: Pharmacokinetic

Interventions

Pharmacokinetic OTHER

Analysis of blood samples

Pharmacokinetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study involves major patients who have benefited from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anaesthesia in neurosurgery and interventional neuroradiology in adults.

You may qualify if:

• \. Adult patient \> 18 years of age with neurosurgery or neurological interventional radiology for whom invasive monitoring of blood pressure is indicated.
• \. Patient with persistent low blood pressure during the general anesthesia procedure (Fall \> 30% of preoperative MAP registered after patient installation and/or MAP \< 55 mmHg) and achieves the depth of anesthesia objective (BIS 40-50).

You may not qualify if:

• \. A patient on a continuous infusion of norepinephrine or other catecholamine initiated in another department or facility or whose start was not recorded or whose dosage changes were unknown.
• \. All causes of hypotension related to the patient's intervention or illness.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service Anesthésie-Réanimation - Hôpital Lariboisière

Paris, 75010, France

Location

Related Publications (3)

• Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.

  PMID: 26181335 BACKGROUND

• Moerman AT, Vanbiervliet VM, Van Wesemael A, Bouchez SM, Wouters PF, De Hert SG. Assessment of Cerebral Autoregulation Patterns with Near-infrared Spectroscopy during Pharmacological-induced Pressure Changes. Anesthesiology. 2015 Aug;123(2):327-35. doi: 10.1097/ALN.0000000000000715.

  PMID: 26035251 BACKGROUND

• Kindermans M, Joachim J, Manquat E, Leve C, Hong A, Mateo J, Mebazaa A, Gayat E, De Backer D, Vallee F. Micro- and macrocirculatory effects of norepinephrine on anaesthesia-induced hypotension: a prospective preliminary study. BMC Anesthesiol. 2023 Nov 16;23(1):374. doi: 10.1186/s12871-023-02342-3.

  PMID: 37974084 DERIVED

MeSH Terms

Interventions

Pharmacogenomic Variants

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Officials

• Vallée Fabrice, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 5, 2018
• Study Start: June 27, 2018
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

FR (1)