Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Modelling of Norepinephrine in Patients Under Target Controlled Infusions (TCI) for Anaesthesia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Neurosurgery
Intervention
Eligibility:
All Genders
18+ years
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 ove...
Detailed Description
Main objective Establish a pharmacokinetic relationship between plasma concentration and the effect of norepinephrine in patients under concentration-target intravenous anesthesia by identifying signi...
Eligibility Criteria
Inclusion
- 1\. Adult patient \> 18 years of age with neurosurgery or neurological interventional radiology for whom invasive monitoring of blood pressure is indicated.
- 2\. 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).
Exclusion
- 1\. 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.
- 2\. All causes of hypotension related to the patient's intervention or illness.
Key Trial Info
Start Date :
June 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03454204
Start Date
June 27 2018
End Date
June 27 2023
Last Update
September 14 2023
Active Locations (1)
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1
Service Anesthésie-Réanimation - Hôpital Lariboisière
Paris, France, 75010