Phase 4
N=3,626
Norepinephrine vs Phenylephrine During General Anesthesia
Anesthesia · Surgery · Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT04789330 ↗Enrolled (actual)
3,626
Serious AEs
1.2%
Results posted
Dec 2025
Primary outcome: Primary: Number of Participants With Assigned Vasopressor Given — 1570; 1627 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Norepinephrine (Drug); Phenylephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Assigned Vasopressor Given |
1570; 1627 | — |
| SECONDARY Number of Participants Who Died Within 30 Days After Surgery |
20; 22 | — |
| SECONDARY Number of Participants With Acute Kidney Injury (AKI) |
140; 135 | — |
| SECONDARY Number of Participants With Severe Acute Kidney Injury |
28; 31 | — |
| SECONDARY Hospital Length of Stay |
4; 4.1 | — |
| SECONDARY Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS) |
44; 38 | — |
| SECONDARY Adverse Cardio-renal Events |
168; 159 | — |
| SECONDARY Rehospitalization Within 30 Days |
56; 66 | — |
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.
Eligibility Criteria
Inclusion Criteria
- age 18 Years and older
- Surgery under general anesthesia and requiring infusion of vasopressors to maintain the mean arterial pressure.
- Surgery duration>2 hours
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04789330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.