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Not yet recruiting NCT06844201

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

Observational Ephedrine Norepinephrine Postoperative Delirium (POD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ephedrine, Norepinephrine.
Who it may be relevant to
Registry conditions: Ephedrine, Norepinephrine, Postoperative Delirium (POD). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Drug Ephedrine
    Received ephedrine the same day of surgery.
  • Drug Norepinephrine
    Received norepinephrine the same day of surgery.

Primary outcome measures

  • Postoperative delirium [Time frame: Within 7 days following surgery.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06844201 · Ephedrine vs Norepinephrine

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗