INDUCT: Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Continuous norepinephrine administration
|
Procedure: Continuous norepinephrine administration
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.
|
| No Intervention: Bolus norepinephrine administration
|
Outcome Measures
Primary Outcome Measures
- Hypotension during anesthetic induction [First 15 minutes of anesthetic induction]
Area under a MAP of 65 mmHg [mmHg x min]
Secondary Outcome Measures
- Hypotension during anesthetic induction [First 15 minutes of anesthetic induction]
Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]
- Hypotension during anesthetic induction [First 15 minutes of anesthetic induction]
Duration of a MAP <65, <60, <50, and <40 mmHg [min]
- Hypertension during anesthetic induction [First 15 minutes of anesthetic induction]
Duration of a MAP >100, >110, >120, and >140 mmHg [min]
- Hypertension during anesthetic induction [First 15 minutes of anesthetic induction]
Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg x min]
- 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
- Hypotension during anesthetic induction [First 15 minutes of anesthetic induction]
Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg
- Hypotension during anesthetic induction [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
- Hypotension during anesthetic induction [First 15 minutes of anesthetic induction]
Cumulative dose of norepinephrine indexed to body weight [μg kg-1]
Eligibility Criteria
Criteria
Inclusion Criteria:
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non-cardiac surgery
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45 years of age
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American Society of Anesthesiologists physical status classification II, III, and IV.
Exclusion Criteria:
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Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter
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Emergency surgery
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Transplant surgery
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History of organ transplant
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Pregnancy
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Heart rhythms other than sinus rhythm
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Impossible Finger-cuff blood pressure monitoring
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Rapid sequence induction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Hamburg-Eppendorf | Hamburg | Germany | 20251 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-100999-BO-ff