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Not yet recruitingNCT06844201Updated Feb 25, 2025

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

An observational study in Ephedrine, Norepinephrine and Postoperative Delirium (POD), sponsored by Riverside University Health System Medical Center. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by Riverside University Health System Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Sex
All
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Study summary

This retrospective study aims to investigate the effects of norepinephrine compared to ephedrine, administered on the day of surgery, on the incidence of postoperative delirium.

Read the detailed description

This retrospective analysis will be conducted using data from the TriNetX US Collaborative Network. This study was designed to assess the impact of intraoperative norepinephrine versus intraoperative ephedrine use on postoperative delirium. Inclusion criteria includes patients who underwent surgery (CPT code 1003143) and were either administered ephedrine or norepinephrine on the day of surgery and did not receive both vasopressors on the day of surgery. Exclusion criteria exclude patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures; patients who were administered epinephrine or dopamine on the day of surgery; patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery to account for patients that might have required pressor infusions for other causes; or a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03).

Propensity score matching through TriNetX will be used to adjust for age, sex, race, BMI, and comorbidities including cerebrovascular disease (ICD-10 code I60-I69), chronic heart failure (I11.0), primary hypertension (I10, I11.9), chronic obstructive pulmonary disease (COPD) (J42, J43, J44, J47), asthma (J45), chronic kidney disease (CKD) (I12, I13), diabetes mellitus (E08-E13), depression (F32.A), schizoaffective disorders (F25), alcohol and drug abuse (F10.1, F10.2, Z71.4), smoking status (F17.2, F17.21), and history of antipsychotic (CN700) and benzodiazepine (C302) usage.

Independent t-tests and chi-squared tests will be used to compare postoperative delirium across the cohorts. To evaluate the relationship between norepinephrine and postoperative delirium versus ephedrine and postoperative delirium, risk differences, and risk ratios with 95% CIs will be calculated following propensity score matching. The TriNetX platform will be used for all analyses, with p \< 0.05 representing statistical significance.

02

Conditions studied

  • Ephedrine
  • Norepinephrine
  • Postoperative Delirium (POD)

Keywords

  • Ephedrine
  • Norepinephrine
  • Postoperative delirium
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Riverside University Health System Medical Center is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients within the TriNetX database.

Eligibility criteria

Ephedrine group:

Inclusion Criteria:

  • underwent surgery (CPT code 1003143)
  • administered ephedrine on the day of surgery

Exclusion Criteria:

  • received both vasopressors (ephedrine and norepinephrine) on the day of surgery.
  • patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures
  • patients who were administered epinephrine or dopamine on the day of surgery
  • patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery
  • a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03)

Norepinephrine group:

Inclusion Criteria:

  • underwent surgery (CPT code 1003143)
  • administered norepinephrine on the day of surgery

Exclusion Criteria:

  • received both vasopressors (ephedrine and norepinephrine) on the day of surgery.
  • patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures
  • patients who were administered epinephrine or dopamine on the day of surgery
  • patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery
  • a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Ephedrine group

    This group received ephedrine on the day of surgery.

    Drug: Ephedrine

  • Norepinephrine group

    This group received norepinephrine on the day of surgery.

    Drug: Norepinephrine

Interventions

  • DrugEphedrine

    Received ephedrine the same day of surgery.

  • DrugNorepinephrine

    Received norepinephrine the same day of surgery.

06

What researchers measure

Primary outcomes

  1. Postoperative delirium

    The outcome of postoperative delirium will be observed using the ICD-10 codes F05, R40, and R41 for delirium, somnolence, and disorientation, respectively.

    Time frame: Within 7 days following surgery.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — We do not have an IPD in place at this time.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06844201
Lead sponsor
Riverside University Health System Medical Center
Responsible party
Christopher Baker (Research Coordinator, Riverside University Health System Medical Center) — Principal investigator
First posted
Feb 25, 2025
Start date
Feb 20, 2025 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Feb 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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