Postinduction Hypotension
Conditions
Keywords
postinduction hypotension, non-cardiac surgery, norepinephrine, bolus, hypotension, continuous
Brief summary
INDUCT-Multi is a multicenter randomized trial investigating whether continuous, compared to bolus, administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients.
Detailed description
Hypotension after induction of general anesthesia, referred to as postinduction hypotension, is common in patients having non-cardiac surgery and is associated with acute kidney injury. Risk factors for postinduction hypotension include older age, higher American Society of Anesthesiologists physical status, chronic arterial hypertension - and higher doses of vasodilating anesthetic drugs. It is reasonable to assume that careful anesthetic management can help maintain blood pressure stability and limit postinduction hypotension. Consistent with this assumption, continuous blood pressure monitoring with an arterial catheter during induction of general anesthesia helps clinicians reduce postinduction hypotension - and is thus recommended in non-cardiac surgery patients at risk for hypotension-related complications. Besides continuous monitoring, anesthesiologists routinely give vasopressors - such as norepinephrine - to maintain blood pressure. Norepinephrine is a fast acting vasopressor with a short half-life and is usually given as repeated manual boluses during induction of general anesthesia. Given as a bolus, it effectively and rapidly increases blood pressure. However, boluses need to be frequently repeated and well-timed to ensure blood pressure stability. In a single-center randomized trial, we demonstrated that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia helps maintain blood pressure stability in high-risk non cardiac surgery patients. We now aim to test the hypothesis that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients who have continuous blood pressure monitoring with an arterial catheter.
Interventions
In patients assigned to continuous administration of norepinephrine, a syringe infusion pump will be prepared and connected to a peripheral or central venous catheter. The responsible anesthesiologist will start the norepinephrine infusion and adjust the infusion rate as necessary and may administer additional norepinephrine boluses via the syringe infusion pump if required.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We will include consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia with planned continuous intra-arterial blood pressure monitoring with a radial arterial catheter and with at least two of the following risk criteria for developing acute kidney injury: * Age ≥65 years * ASA physical status III or IV * Chronic arterial hypertension * Diabetes mellitus requiring medication * Intra-abdominal surgery * Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)
Exclusion criteria
* Pregnancy * Cardiac arrhythmia * History of intracranial hemorrhage or intracranial aneurysm * Clinical indication for continuous norepinephrine infusion during induction of general anesthesia (e.g., severe aortic valve stenosis, coronary artery disease, or heart failure) * Patients who are unable to understand, read, and provide informed consent in German
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
Secondary
| Measure | Time frame |
|---|---|
| Area under a MAP of 60 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Area under a MAP of 50 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Area under a MAP of 40 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Area above a MAP of 100 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Area above a MAP of 110 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Area above a MAP of 120 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Area above a MAP of 140 mmHg (mmHg x min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP <65 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP <60 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP <50 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP <40 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP >100 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP >110 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP >120 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Duration of a MAP >140 mmHg (min) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement <65 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement <60 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement <50 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement <40 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement >100 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement >110 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement >120 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with any MAP measurement >140 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <65 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <60 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <50 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <40 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >100 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >110 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >120 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >140 mmHg | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
| Cumulative dose of norepinephrine indexed to body weight (µg kg-1) | First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent. |
Countries
Germany
Contacts
CONTACTKristen K Thomsen, MD
Outcome results
None listed