Norepinephrine vs Phenylephrine During General Anesthesia

NCT04789330 | Completed Phase 4 Results FDA Drug

• 1 other identifier: A135759
• Study Type: interventional
• Target: 3,626
• Locations: 1 country
• Sites: 5

Brief Summary

50 million patients undergo surgery each year in the United States. Postoperative mortality is considered the third leading cause of death worldwide. Hypotension during surgery have been linked to increased postoperative morbidity and mortality. Episodes of hypotension during surgery are associated with an increased risk of acute kidney injury, stroke, cardiac events and death. Treating or preventing hypotension during general anesthesia and major surgery was found to improve outcomes. At this time, it is unclear what is the best vasopressor to maintain blood pressure during surgery under general anesthesia. With this pilot pragmatic trial, the investigators will explore the impact of norepinephrine (NE) or phenylephrine (PE) on post-operative events in patients undergoing major surgery with general anesthesia and needing vasopressors infusion to maintain their systemic arterial pressure.

Conditions

Hypotension; Anesthesia; Surgery

Keywords

vasopressor; outcome; AKI; cardiovascular; complications

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Assigned Vasopressor Given

  First line vasopressor administration will be measured as a percent of total eligible participants with assigned vasopressor given during anesthesia time, up to 24 hours

  Anesthesia time, up to 24 hours

Secondary Outcomes (7)

• Number of Participants Who Died Within 30 Days After Surgery

  30 days

• Number of Participants With Acute Kidney Injury (AKI)

  7 days

• Number of Participants With Severe Acute Kidney Injury

  7 days

• Hospital Length of Stay

  In-hospital, up to 30 days

• Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)

  7 days

Study Arms (2)

Norepinephrine

ACTIVE COMPARATOR

Norepinephrine continuous infusion as the first line vasopressor

Drug: Norepinephrine

Phenylephrine

ACTIVE COMPARATOR

Phenylephrine continuous infusion as the first line vasopressor

Drug: Phenylephrine

Interventions

Norepinephrine DRUG

Norepinephrine administered during anesthesia

Norepinephrine

Phenylephrine DRUG

Phenylephrine administered during anesthesia

Phenylephrine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 Years and older
• Surgery under general anesthesia and requiring infusion of vasopressors to maintain the mean arterial pressure.
• Surgery duration\>2 hours

You may not qualify if:

• Cardiac surgery
• Patients on ECMO
• Organ transplantation
• Outpatient (come-and-go surgery)
• Obstetric procedures
• Patient already receiving NE or PE before induction of anesthesia
• Patients transferred immediately (i.e. within 24 hours) after surgery to another hospital.
• Patients with severe trauma

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (5)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

UCSF Medical Center at Mount Zion

San Francisco, California, 94115, United States

Location

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

Location

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

Location

Related Publications (2)

• Legrand M, Kothari R, Fong N, Palaniappa N, Boldt D, Chen LL, Kurien P, Gabel E, Sturgess-DaPrato J, Harhay MO, Pirracchio R, Bokoch MP; VEGA-1 trial investigators. Norepinephrine versus phenylephrine for treating hypotension during general anaesthesia in adult patients undergoing major noncardiac surgery: a multicentre, open-label, cluster-randomised, crossover, feasibility, and pilot trial. Br J Anaesth. 2023 May;130(5):519-527. doi: 10.1016/j.bja.2023.02.004. Epub 2023 Mar 14.

  PMID: 36925330 RESULT

• Krone S, Bokoch MP, Kothari R, Fong N, Tallarico RT, Sturgess-DaPrato J, Pirracchio R, Zarbock A, Legrand M. Association between peripheral perfusion index and postoperative acute kidney injury in major noncardiac surgery patients receiving continuous vasopressors: a post hoc exploratory analysis of the VEGA-1 trial. Br J Anaesth. 2024 Apr;132(4):685-694. doi: 10.1016/j.bja.2023.11.054. Epub 2024 Jan 19.

  PMID: 38242802 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine; Phenylephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Pragmatic trial with events recorded throughout the eHR

Results Point of Contact

• Title: Matthieu LEGRAND MD, PhD
• Organization: University of California, San Francisco

matthieu.legrand@ucsf.edu

415-885-7388

Study Officials

• Matthieu LEGRAND, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pragmatic, cluster-randomized, open-labeled, multiple-crossover trial

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: July 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)