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The goal of this clinical trial is to compare the effect of opioid-free anesthesia on the intensity of acute and chronic postoperative pain in patients undergoing cardiac surgery. The study will also evaluate the safety of opioid-free anesthesia in this patient population.
The main questions it aims to answer are:
Additionally, the incidence of adverse events-including postoperative delirium (POD), hemodynamic instability, respiratory complications, constipation, and postoperative nausea and vomiting (PONV)-as well as overall treatment outcomes, will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-Free Anesthesia Groupe | Experimental | Patients in the opioid-free group will receive anesthesia without any opioids. |
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| Opioid anesthesia groupe | Active Comparator | In the opioid group, patients will receive conventional opioid-based anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Free Anaesthesia | Procedure | Anesthesia will consist of a multimodal combination of general non-opioid agents (propofol, dexmedetomidine, midazolam, sevoflurane, and esketamine) supplemented by regional anesthesia techniques, including the erector spinae plane block (ESPB), serratus anterior plane block, and parasternal block. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute postoperativ pain | Postoperative pain will be assessed using the Numeric Rating Pain Scale (NRPS/NRS 0-10) after cardiac surgery | Assessments will be performed upon extubation (T0) and then every 12 hours for the first 48 postoperative hours (at 12, 24, 36, and 48 hours). |
| Chronich postoperative pain | Assessed using NRS (0-10) for average and worst pain intensity. Analgesic medication use (type and dose) related to the surgery will also be recorded at this time point. | Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone |
| Measure | Description | Time Frame |
|---|---|---|
| Incidency of potsoperativ delirium | The occurrence of postoperative delirium will be monitored using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The incidence of delirium is defined as at least one positive C | Screening will begin after extubation and will be performed twice daily (once in the morning and once in the evening) for the first 5 postoperative days or until discharge from the hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dejan Markovic, MD, PhD, Associated Professor | Contact | +381668300903 | drdejanmarkovic@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Center of Serbia | Belgrade | Serbia |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Opioid Anesthesia | Procedure | This will include intraoperative opioids (e.g., fentanyl or sufentanil) in combination with general anesthetic agents such as propofol, sevoflurane, and midazolam, supplemented by additional analgesics as required. Regional anesthesia techniques (e.g., erector spinae plane block, serratus anterior plane block, or parasternal block) may also be performed at the discretion of the attending anesthesiologist |
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| D006571 |
| Heterocyclic Compounds |