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NCT Number: NCT07538388

Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous norepinephrine administration

Procedure

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 outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Duration of a MAP >110 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.

  14. Duration of a MAP >120 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.

  15. Duration of a MAP >140 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.

  16. Absolute (n) and relative (%) number of patients with any MAP measurement <65 mmHg

    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.

  17. Absolute (n) and relative (%) number of patients with any MAP measurement <60 mmHg

    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.

  18. Absolute (n) and relative (%) number of patients with any MAP measurement <50 mmHg

    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.

  19. Absolute (n) and relative (%) number of patients with any MAP measurement <40 mmHg

    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.

  20. Absolute (n) and relative (%) number of patients with any MAP measurement >100 mmHg

    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.

  21. Absolute (n) and relative (%) number of patients with any MAP measurement >110 mmHg

    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.

  22. Absolute (n) and relative (%) number of patients with any MAP measurement >120 mmHg

    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.

  23. Absolute (n) and relative (%) number of patients with any MAP measurement >140 mmHg

    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.

  24. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <65 mmHg

    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.

  25. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <60 mmHg

    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.

  26. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <50 mmHg

    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.

  27. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <40 mmHg

    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.

  28. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >100 mmHg

    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.

  29. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >110 mmHg

    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.

  30. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >120 mmHg

    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.

  31. Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >140 mmHg

    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.

  32. Cumulative dose of norepinephrine indexed to body weight (µg kg-1)

    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.

Other outcomes

  1. Acute kidney injury

    Time frame: Within the first 3 postoperative days

  2. Nonfatal cardiac arrest

    Time frame: Within the first 3 postoperative days

  3. Myocardial infarction

    Time frame: Within the first 3 postoperative days

  4. Death

    Time frame: Within the first 3 postoperative days

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen K Thomsen, MD

CONTACT

[email protected]

+4940741070215

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension in High-Risk Non-Cardiac Surgery Patients - The Multicenter INDUCT Trial (INDUCT-Multi)

Acronym: INDUCT-Multi

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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