Comparing Esketamine and Opioids for Heart Protection During Surgery
Perioperative Cardiovascular Protection Conservative Effects of Esketamine Versus µ-opioid Receptor Agonists in Total Intravenous General Anesthesia: Study Protocol for a Randomized Controlled Pilot Trial
This study is testing whether using Esketamine instead of traditional opioids during surgery can better protect the heart and improve outcomes for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Second Hospital of Shanxi Medical University Academic / other |
| Locations | 1 site (Taiyuan, Shanxi) |
| Trial ID | NCT04553536 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the cardiovascular effects of using Esketamine versus traditional µ-opioid receptor agonists in patients undergoing general anesthesia. It aims to understand how different analgesics impact the incidence of adverse cardiovascular events and the levels of cardiac troponin I during and after surgery. The study will involve 1,000 patients across eleven centers in Shanxi province, China, and will monitor various physiological parameters and blood samples to assess the outcomes. The hypothesis is that over-analgesia with opioids may lead to cardiovascular de-protection, potentially worsening patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged over 16 years undergoing general anesthesia with ASA Physical Status 1-II.
Not a fit: Patients with diabetes and neuropathy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular safety during surgeries by optimizing pain management strategies.
How similar studies have performed: While the approach of comparing analgesics in anesthesia is common, the specific focus on cardiovascular protection through this mechanism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing general anesthesia Exclusion Criteria: * Patients with diabetes and neuropathy
Where this trial is running
Taiyuan, Shanxi
- Zheng Guo — Taiyuan, Shanxi, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.