Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

NCT06844201 | Not Yet Recruiting

• 1 other identifier: Ephedrine vs Norepinephrine
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ephedrine; Norepinephrine; Postoperative Delirium (POD)

Keywords

Ephedrine; Norepinephrine; Postoperative delirium

Outcome Measures

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.

  Within 7 days following surgery.

Study Arms (2)

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

Ephedrine DRUG

Received ephedrine the same day of surgery.

Ephedrine group

Norepinephrine DRUG

Received norepinephrine the same day of surgery.

Norepinephrine group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients within the TriNetX database.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riverside University Health System Medical Center: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Ephedrine; Norepinephrine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: February 20, 2025
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share