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

NCT05940649 | Completed

• 1 other identifier: 2023-100999-BO-ff
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• Hypotension during anesthetic induction

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

  First 15 minutes of anesthetic induction

Secondary Outcomes (8)

• Hypotension during anesthetic induction

  First 15 minutes of anesthetic induction

• Hypotension during anesthetic induction

  First 15 minutes of anesthetic induction

• Hypertension during anesthetic induction

  First 15 minutes of anesthetic induction

• Hypertension during anesthetic induction

  First 15 minutes of anesthetic induction

• Hypertension during anesthetic induction

  First 15 minutes of anesthetic induction

Study Arms (2)

Continuous norepinephrine administration

EXPERIMENTAL

Procedure: Continuous norepinephrine administration

Bolus norepinephrine administration

NO INTERVENTION

Interventions

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.

Continuous norepinephrine administration

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristen Thomsen: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20251, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: July 3, 2023
• Primary Completion: June 6, 2024
• Study Completion: July 1, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)