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NCT Number: NCT06844201

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ephedrine

Drug

Received ephedrine the same day of surgery.

norepinephrine

Drug

Received norepinephrine the same day of surgery.

Primary outcomes

  1. Postoperative delirium

    Time frame: Within 7 days following surgery.

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

Sponsors and collaborators

Lead sponsor

Riverside University Health System Medical Center

Other

Registry information

Official study title

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine: a Retrospective TriNetX Database Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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