University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany
NCT Number: NCT05940649
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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Notify Me45 year and older
All sexes
Interventional
Not applicable
Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: First 15 minutes of anesthetic induction
Area under a MAP of 65 mmHg [mmHg x min]
Time frame: First 15 minutes of anesthetic induction
Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]
Time frame: First 15 minutes of anesthetic induction
Duration of a MAP <65, <60, <50, and <40 mmHg [min]
Time frame: First 15 minutes of anesthetic induction
Duration of a MAP >100, >110, >120, and >140 mmHg [min]
Time frame: First 15 minutes of anesthetic induction
Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg x min]
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
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
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
Time frame: First 15 minutes of anesthetic induction
Cumulative dose of norepinephrine indexed to body weight [μg kg-1]
Kristen Thomsen
Other
Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial
Acronym: INDUCT
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