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NCT Number: NCT05940649

Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction

Intraoperative hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury and death. The timely treatment of intraoperative hypotension is thus important to avoid postoperative complications. About one third of intraoperative hypotension occurs during anesthetic induction - i.e., between the start of anesthetic induction and surgical incision. Hypotension during anesthetic induction is associated with postoperative acute kidney injury.

Unmodifiable risk factors for hypotension during anesthetic induction include age, male sex, and a high American Society of Anesthesiologists physical status class. However, hypotension during anesthetic induction is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation.

In most German hospitals, norepinephrine is the first-line vasopressor to treat hypotension during anesthetic induction. Norepinephrine is usually given as repeated manual boluses of 5, 10, or 20 μg. The continuous administration of norepinephrine via a perfusion pump is usually started only later. It remains unknown whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction.

We thus propose to investigate whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction in 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

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • non-cardiac surgery
  • >45 years of age
  • American Society of Anesthesiologists physical status classification II, III, and IV.

Exclusion criteria

  • Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter
  • Emergency surgery
  • Transplant surgery
  • History of organ transplant
  • Pregnancy
  • Heart rhythms other than sinus rhythm
  • Impossible Finger-cuff blood pressure monitoring
  • Rapid sequence induction

Treatment and study plan

Continuous norepinephrine administration

Procedure

In patients randomized to continuous norepinephrine administration, hypotension (= mean arterial pressure < 65mmHg) will be treated with continuous norepinephrine infusion. The norepinephrine perfusion line will be connected to the saline infusion line using a three-way valve. Treating anesthesiologists will be free to reduce or increase the norepinephrine infusion rate anytime.

Primary outcomes

  1. Hypotension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Area under a MAP of 65 mmHg [mmHg x min]

Secondary outcomes

  1. Hypotension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]

  2. Hypotension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Duration of a MAP <65, <60, <50, and <40 mmHg [min]

  3. Hypertension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Duration of a MAP >100, >110, >120, and >140 mmHg [min]

  4. Hypertension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg x min]

  5. Hypertension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Absolute [n] and relative [%] number of patients with any MAP measurement >100, >110, >120 and >140 mmHg

  6. Hypotension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg

  7. Hypotension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg

  8. Hypotension during anesthetic induction

    Time frame: First 15 minutes of anesthetic induction

    Cumulative dose of norepinephrine indexed to body weight [μg kg-1]

Sponsors and collaborators

Lead sponsor

Kristen Thomsen

Other

Registry information

Official study title

Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial

Acronym: INDUCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Nov 15, 2024

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

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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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