Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

NCT ID: NCT06844201

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-20

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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Ephedrine Norepinephrine Postoperative Delirium (POD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ephedrine group

This group received ephedrine on the day of surgery.

Ephedrine

Intervention Type DRUG

Received ephedrine the same day of surgery.

Norepinephrine group

This group received norepinephrine on the day of surgery.

Norepinephrine

Intervention Type DRUG

Received norepinephrine the same day of surgery.

Interventions

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Ephedrine

Received ephedrine the same day of surgery.

Intervention Type DRUG

Norepinephrine

Received norepinephrine the same day of surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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


* 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)

Norepinephrine group:


* 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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riverside University Health System Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christopher Baker

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Ephedrine vs Norepinephrine

Identifier Type: -

Identifier Source: org_study_id

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