Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Norepinephrine Administration.
- Who it may be relevant to
- Registry conditions: Postinduction Hypotension. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension in High-Risk Non-Cardiac Surgery Patients - The Multicenter INDUCT Trial (INDUCT-Multi)
Overview
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
- Procedure Continuous Norepinephrine Administration
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.
Primary outcome measures
- Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min) [Time frame: 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 outcome measures (12)
- Area under a MAP of 60 mmHg (mmHg x min) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 4 centers
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charit — Berlin
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University D — Düsseldorf
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, Univer — Hamburg
- Department of Anaesthesiology, University Hospital LMU Munich — München
Identifiers
NCT: NCT07538388 · 2025-101645-BO-ff