Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction
- Conditions
- Intraoperative Hypotension
- Interventions
- Procedure: Continuous norepinephrine administration
- Registration Number
- NCT05940649
- Lead Sponsor
- Kristen Thomsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 262
- non-cardiac surgery
- >45 years of age
- American Society of Anesthesiologists physical status classification II, III, and IV.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous norepinephrine administration Continuous norepinephrine administration -
- Primary Outcome Measures
Name Time Method Hypotension during anesthetic induction First 15 minutes of anesthetic induction Area under a MAP of 65 mmHg \[mmHg x min\]
- Secondary Outcome Measures
Name Time Method Hypotension during anesthetic induction First 15 minutes of anesthetic induction Cumulative dose of norepinephrine indexed to body weight \[μg kg-1\]
Hypertension during anesthetic induction First 15 minutes of anesthetic induction Absolute \[n\] and relative \[%\] number of patients with any MAP measurement \>100, \>110, \>120 and \>140 mmHg
Trial Locations
- Locations (1)
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany