Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study
Condition: Hypotension; Anesthesia; Hypotension on Induction
MeSH terms: Hypotension
Study type: Interventional

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.
    

Intervention name(s): Monitoring; Norepinephrine preparation; Propofol administration; Alarm adjustment; Intervention threshold
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Continuous blood pressure monitoring; Norepinephrine infusion will be prepared and connected to peripheral or central venous catheter (infusion will not be started); Propofol infusion will be started only when clinical effects of opioid are noticeable: 1.5 mg/kg propofol in patients less than 55 years old and 1.0 mg/kg propofol in patients 55 years or older over 90 seconds; Lower mean arterial pressure alarm threshold will be set to 75 mmHg; Lower mean arterial pressure intervention threshold will be 75 mmHg: continuous norepinephrine infusion will be started when mean arterial blood decreases below 75 mmHg
Intervention MeSH terms: Norepinephrine; Propofol
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, single center, clinical interventional proof-of-concept study in 120 patients scheduled for elective major non-cardiac surgery at the University Medical Center Hamburg-Eppendorf.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypotension; Low Blood Pressure; Anesthesia Induction; Surgery