EphedrineNCT06844201
Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine
An observational study of Ephedrine and Norepinephrine, run by Riverside University Health System Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ephedrine, Norepinephrine, Postoperative Delirium (POD)
- What is being tested?
- Ephedrine and Norepinephrine
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2025to 1 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients within the TriNetX database.
Who may be able to join
- underwent surgery (CPT code 1003143)
- administered ephedrine on the day of surgery
- underwent surgery (CPT code 1003143)
- administered norepinephrine on the day of surgery
Who cannot join
- 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:
Show all 11Show fewer
- 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)
About this study
Official title: Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine: a Retrospective TriNetX Database Study
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.
Read the 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.
- Conditions
- Ephedrine, Norepinephrine, Postoperative Delirium (POD)
- Being tested
- Ephedrine, Norepinephrine
- Keywords
- Ephedrine, Norepinephrine, Postoperative delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Received ephedrine the same day of surgery.
NorepinephrineDrug
Received norepinephrine the same day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine group | This group received ephedrine on the day of surgery. Receives: Drug: Ephedrine | |
| Norepinephrine group | This group received norepinephrine on the day of surgery. Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EphedrineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riverside University Health System Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Baker, Riverside University Health System Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844201
- Sponsor's protocol ID
- Ephedrine vs Norepinephrine
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have an IPD in place at this time.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine: a Retrospective TriNetX Database Study
- ClinicalTrials.gov ID
- NCT06844201
- Acronym / sponsor ID
- Ephedrine vs Norepinephrine
- Conditions
- Ephedrine, Norepinephrine, Postoperative Delirium (POD)
- Keywords
- Ephedrine, Norepinephrine, Postoperative delirium
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Riverside University Health System Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ephedrine group | – | Drug: EphedrineThis group received ephedrine on the day of surgery. |
| Norepinephrine group | – | Drug: NorepinephrineThis group received norepinephrine on the day of surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients within the TriNetX database.
Key inclusion criteria (4 listed)
- underwent surgery (CPT code 1003143)
- administered ephedrine on the day of surgery
- underwent surgery (CPT code 1003143)
- administered norepinephrine on the day of surgery
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EphedrineReceived ephedrine the same day of surgery. | Drug | Ephedrine group |
| NorepinephrineReceived norepinephrine the same day of surgery. | Drug | Norepinephrine group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No. We do not have an IPD in place at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ephedrine and Norepinephrine, run by Riverside University Health System Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: Within 7 days following surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.