← Back to Search

Alpha-2 Adrenergic Agonist

Dexmedetomidine for Postoperative Cognitive Dysfunction (CODEX Trial)

Phase 4

Recruiting

Led By Stephen Choi, MD,MSc,FRCPC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)

Age ≥60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12 months

Awards & highlights

CODEX Trial Summary

This trial is testing whether the drug Dexmedetomidine can prevent postoperative cognitive dysfunction (POCD), which is when patients have trouble thinking and remembering after surgery.

Who is the study for?

This trial is for cardiac surgery patients aged 60 or older who are recovering in the CVICU and can complete cognitive tests post-surgery. It's not for those with major pre-op cognitive issues, certain heart conditions, severe liver or kidney disease, or an allergy to dexmedetomidine.Check my eligibility

What is being tested?

The study is testing whether Dexmedetomidine (DEX) can prevent long-term memory and thinking problems after cardiac surgery. The goal is to see if DEX improves recovery and reduces hospital stay and healthcare costs.See study design

What are the potential side effects?

Possible side effects of Dexmedetomidine may include slow heart rate, low blood pressure, dry mouth, nausea. In rare cases it might cause serious allergic reactions.

CODEX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for heart surgery that requires opening my chest, with initial recovery in the CVICU.

Select...

I am 60 years old or older.

CODEX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-operative cognitive dysfunction

Secondary outcome measures

Delirium

Depressive symptoms

In-hospital mortality for index surgery

+7 more

CODEX Trial Design

2Treatment groups

Active Control

Group I: Dexmedetomidine Hydrochloride GroupActive Control1 Intervention

Patients will receive a loading dose of 1.2 μg/kg dexmedetomidine prior to transfer to CVICU over 20 min immediately postoperative, followed by continuous infusion of 0.3 μg/kg/h for up to 12 hours or until patient is ready for discharge from CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.

Group II: Standard of Care GroupActive Control1 Intervention

Standard sedation protocols will be followed at the discretion of the attending physician.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

London Health Sciences CentreOTHER

142 Previous Clinical Trials

47,518 Total Patients Enrolled

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,548,908 Total Patients Enrolled

McMaster UniversityOTHER

881 Previous Clinical Trials

2,595,486 Total Patients Enrolled

Media Library

Dexmedetomidine Hydrochloride (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04289142 — Phase 4

Cognitive Impairment Research Study Groups: Dexmedetomidine Hydrochloride Group, Standard of Care Group

Cognitive Impairment Clinical Trial 2023: Dexmedetomidine Hydrochloride Highlights & Side Effects. Trial Name: NCT04289142 — Phase 4

Dexmedetomidine Hydrochloride (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04289142 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for volunteers to join this research initiative?

"Affirmative. Based on the information presented on clinicaltrials.gov, this research is currently recruiting patients and has been since December 1st 2019. 2400 participants are needed from one trial site to meet quota and the data was last refreshed on March 14th 2022."

Answered by AI

What indications are most commonly addressed with Dexmedetomidine Hydrochloride?

"Multiple ailments, including disease-induced ventilations, mechanical cyclic vomiting syndrome can be addressed by utilizing Dexmedetomidine Hydrochloride Group."

Answered by AI

Could you kindly provide a historical overview of the research surrounding Dexmedetomidine Hydrochloride Group?

"Currently, there are 110 clinical trials active in the Dexmedetomidine Hydrochloride Group domain with 23 of them being at Phase 3. The majority of these studies have been conducted within Karachi, Sindh but numerous other medical facilities around the world have taken part as well - totaling 207 locations."

Answered by AI

Has the FDA sanctioned Dexmedetomidine Hydrochloride Group?

"There is extensive clinical data confirming the safety of dexmedetomidine hydrochloride, thus it has been awarded a score of 3 in our assessment."

Answered by AI

How many individuals are being selected to partake in this experiment?

"Yes, indeed. Data on clinicaltrials.gov displays that this investigation is actively searching for participants; the trial was initially announced on December 1st 2019 and most recently modified on March 14th 2022. The research requires 2400 patients from a single location to be enrolled in the study."

Answered by AI

Recent research and studies

BMJ OpenJournal

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery: CODEX Randomised Controlled Trial Protocol

Choi, Stephen, Angela Jerath, Philip Jones, Sinziana Avramescu, George Djaiani, Summer Syed, Tarit Saha, et al.. 2021. “Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery: CODEX Randomised Controlled Trial Protocol”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-046851.

clinicaltrials.govStudy

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

2019. "Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04289142.

All > Mental Illness > Mild Cognitive Impairment