Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Area under a MAP of 65 mmHg
Study Overview
Brief Summary
In this clinical proof-of-concept study, the aim is to investigate the efficacy of a hypotension avoidance strategy to prevent post-induction hypotension. Specifically, it will be investigate how much postinduction hypotension occurs when using a hypotension avoidance strategy - combining continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension - in high-risk patients having elective non-cardiac surgery.
Detailed Description
Hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury. About one third of hypotension occurs "postinduction" - i.e., after the induction of general anesthesia but before surgical incision. Unmodifiable risk factors for postinduction hypotension include age, male sex, and a high American Society of Anesthesiologists physical status. However, postinduction hypotension is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation. Vasodilation can be effectively treated with vasopressors, e.g. norepinephrine.
It is reasonable to assume that postinduction hypotension is largely avoidable by careful anesthetic and hemodynamic monitoring and management during anesthetic induction. A hypotension avoidance strategy could include continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension. However, it remains unknown to which extent a hypotension avoidance strategy actually can avoid postinduction hypotension. Before testing the effectiveness of hypotension avoidance strategies in large-scale randomized trials it is important to investigate their efficacy.
In this clinical proof-of-concept study, the aim is to investigate the efficacy of a hypotension avoidance strategy to prevent post-induction hypotension. Specifically, it will be investigate how much postinduction hypotension occurs when using a hypotension avoidance strategy - combining continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension - in high-risk patients having elective non-cardiac surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 130 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists physical status classification III or higher, and in whom intraarterial blood pressure monitoring is planned for clinical indication
Exclusion Criteria
- •Emergency surgery
- •Transplant surgery
- •History of organ transplant
- •Pregnancy
- •Contraindications for the use of propofol
- •Rapid sequence induction
Arms & Interventions
Hypotension Avoidance Strategy
After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation.
Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Intervention: Monitoring (Procedure)
Hypotension Avoidance Strategy
After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation.
Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Intervention: Norepinephrine preparation (Procedure)
Hypotension Avoidance Strategy
After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation.
Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Intervention: Alarm adjustment (Procedure)
Hypotension Avoidance Strategy
After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation.
Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Intervention: Intervention threshold (Procedure)
Hypotension Avoidance Strategy
After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation.
Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Intervention: Propofol administration (Procedure)
Outcomes
Primary Outcomes
Area under a MAP of 65 mmHg
Time Frame: First 15 minutes of induction of general anesthesia
Area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction \[mmHg x min\].
Secondary Outcomes
- Any Hypotension(First 15 minutes of induction of general anesthesia)
- Area under threshold(First 15 minutes of induction of general anesthesia)
- 1-minute Hypotension(First 15 minutes of induction of general anesthesia)
- Area above the curve(First 15 minutes of induction of general anesthesia)
- Duration(First 15 minutes of induction of general anesthesia)
- Norepinephrine(First 15 minutes of induction of general anesthesia)