An observational study in Analgesia and Cardiac Surgery, sponsored by Kathirvel Subramaniam. Not yet recruiting at 1 site in United States. Open to participants aged 60 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Kathirvel Subramaniam · Observational
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone in elderly adults undergoing cardiac surgery.
Cardiac surgery patients often experience significant acute postoperative pain, and untreated or undertreated pain has consequences. Each year, 900,000 painful cardiac surgeries occur in the US alone. Pain associated with cardiac surgery results from surgical incision, sternal retraction, internal mammary artery harvesting, saphenous vein removal, placement of mediastinal and chest drains, sternal wires, and release of pro-inflammatory mediators after tissue injury. One study reported that 49%, 62%, and 78% of patients reported severe pain at rest, movement, and coughing, respectively after coronary artery bypass surgery (CABG). Another study showed that 61.4% of patients undergoing cardiac surgery reported moderate to severe pain. Inadequate pain treatment is common in cardiac surgery due to health care providers' fears of causing cardiorespiratory compromise. Poor pain control can trigger sympathoadrenal responses leading to cardiac arrhythmias and myocardial ischemia, restrict mobility to cause venous thrombosis, impair clearance of secretions leading to pulmonary complications such as atelectasis and pneumonia, decrease patient satisfaction and predispose to the development of chronic, persistent surgical pain (CPSP).
Improving clinical practice by shifting paradigms: Our research is transformative and will evolve current reactive clinical practice towards proactive precision methods based on genetic risks for surgical pain and ORADE in elderly vulnerable population. This is the first effort to move in the direction of personalizing perioperative opioid use with precise dosing to improve safety and efficacy in cardiac surgery. Preoperative genotyping-based clinical decisions are expected to support clinical implementation in real-world settings. Importantly, investigators will be able to reach beyond the current best-in-class outcomes with precision multi-dose methadone analgesia based on proactive genetic risk identification to maximize safety and efficacy of opioids in all cardiac surgical patients and positively impact socio-economic outcomes in the future. By addressing these critical barriers, this research will help physicians identify patients at risk and improve the safety and efficacy of opioids and surgical pain management while preventing OD, misuse, overdose, and deaths.
Kathirvel Subramaniam is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Elderly cardiac surgical patients over 60 years of age Both genders are included All races and ethnic groups undergoing elective open cardiac surgery through midline sternotomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Determine Genetic Factors - Opioid Related Adverse Events (RD)
Respiratory depression will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Time frame: Immediately post-surgery during hospital stay
Determine Genetic Factors - Opioid Related Adverse Events (PONV)
Post-operative nausea and vomiting will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Time frame: Immediately post-surgery during hospital stay
Determine Genetic Factors - Opioid Related Adverse Events (Excessive Sedation)
Excessive sedation will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Time frame: Immediately post-surgery during hospital stay
Determine Genetic Factors - Uncontrolled severe pain
We postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and ORM1 genetic variants identify patients at risk for poor pain relief and ORADE with methadone in the immediate post-surgical period. Pain will be measured by the Numerical Rating Scale (NRS) in which 0 = no pain at all and 10 = worst pain imaginable. This will be self-reported responses by the patient.
Time frame: Immediately post-surgery during hospital stay
Opioid use post-operatively
Opioid usage will be recorded via SOAPP-R, a 24-item validated opioid assessment. A score of 18 or higher is considered positive.
Time frame: Post-operative Day 5 to 6-months post-operative
Patient-Reported Outcomes Measurement Information System
The PROMIS-29 v2.0 will be collected for this outcome measure. The PROMIS survey is scored by the following T-Score Cut Points: 20-55 = better health, 55-60 = mild, 61-69 = moderate, and 71+ = worse health. The general population mean = 50 (SD = 10).
Time frame: Post-operative Day 5 to 6-months post-operative
Incidence of Chronic Persistent Surgical Pain (CPSP)
CPSP will be obtained via patient-self report as yes/no responses for follow-up assessments. This measure will be reported as mean(SD) for positive CPSP subjects.
Time frame: Post-operative Day 5 to 6-months post-operative
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Agnosia
Kathirvel Subramaniam