Clinical trial NCT06844201: Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine
Official title: Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine: a Retrospective TriNetX Database Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ephedrine
Norepinephrine
Postoperative Delirium (POD)
Keywords: Ephedrine
Norepinephrine
Postoperative delirium
Lead sponsor: Riverside University Health System Medical Center
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients within the TriNetX database.

Brief 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.

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.

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)

Primary outcomes:
measure: Postoperative delirium
timeFrame: Within 7 days following surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: