Status:
COMPLETED
Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery
Lead Sponsor:
Nantes University Hospital
Conditions:
Cardiac Disorder
Hypotension
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs ...
Eligibility Criteria
Inclusion
- Requiring cardiac or thoracic surgery under general anaesthesia
- Requiring a blood pressure catheter prior to GA induction
Exclusion
- Hemodynamic instability on arrival in the operating room
- Hypotension on arrival in the operating theatre: Systolic blood pressure \< 100 mmHg or Mean arterial pressure \< 65 mmHg
- Hypertension on arrival at the operating theatre: Systolic blood pressure \> 160 mmHg or Mean arterial pressure \> 100 mmHg
- Adult under guardianship, curatorship or safeguard of justice
- Unable to give consent
- Pregnant or breastfeeding woman
- Emergency surgery (cannot be delayed by 24 hours)
- Current participation in an interventional protocol that interferes with the evaluation criteria of the study
- Not affiliated to or not benefiting from a social security scheme
- Lack of informed and written consent from the patient
- Patient with a dilated aorta with a risk of rupture (e.g. chronic dissection for example)
- Patient with severe aortic insufficiency
- Treated hypertensive history that may have hypersensitivity to noradrenaline and hypertensive flares hypertensive attacks
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT05335954
Start Date
April 27 2022
End Date
December 12 2023
Last Update
March 7 2024
Active Locations (1)
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1
Chu de Nantes
Nantes, France