Clinical trial NCT05940649: Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction
Official title: Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Hypotension
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 262
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hypotension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
Secondary outcomes:
measure: Hypotension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
measure: Hypotension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
measure: Hypertension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
measure: Hypertension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
measure: Hypertension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
measure: Hypotension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
measure: Hypotension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
measure: Hypotension during anesthetic induction
timeFrame: First 15 minutes of anesthetic induction
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References: