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Opioid-free anesthesia is feasible and effective but still not common practice. Anesthesia depth monitoring is not investigated for use in anesthesia combining low dose infusions of several drugs with different sedative patterns on EEG. This is an observational study comparing opioid-free anesthesia with regular anesthesia in regards to DSA, SEF and PSI from the Sedline monitor.
Patients who undergo general anaesthesia are more or less extensively monitored, with the sole purpose of surveilling depth of anesthesia and nociception. Parameters such as heart rate, blood pressure, pupillary size and sweating has historically been used as predictive markers for this surveillance. However, these clinical parameters have low predictive capacity and there is a tendency to overdue perioperative sedation and misinterpret sympathetically derived reactions as pain. This could lead to higher incidence of postoperative delirium and opioid induced hyperalgesia. On the contrary, an overestimated trust in the mentioned parameters might lead to increased risk of intra-operative awareness.
The usefulness of processed encephalography (pEEG) during anesthesia has since long been promoted for anesthesia providers. Since then, several commercial devices has been developed and deployed for clinical use. Although mixed results are presented in clinical studies there is now a significant empirical experience for its use in routine anesthesia with volatile anesthetics and propofol. Density spectral array (DSA) is the latest contribution in the field of encephalographic monitoring. It is a two-dimensional graph plotting the power of each frequency-interval on a time-scale.
More and more data on the effectiveness and safety of opioid free anaesthesia (OFA) have been released, especially as a direct result of the ongoing opioid-epidemic affecting a large number of people worldwide. The algorithms for the commercial devices, using DSA, has to this date not been validated for multimodal anesthetic regimens using ketamine and dexmedetomidine.
The purpose of this observational study is to compare DSA pattern and data for pEEG between OFA and total intravenous anaesthesia or general anaesthesia with volatile anesthetics for patients undergoing laparoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-free anesthesia | Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Ketamine Dexmedetomidine Propofol Sevoflurane Lidocaine Betamethasone Paracetamol NSAID |
| |
| Target Controlled Infusion | Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Propofol Remifentanil Oxycodone Paracetamol NSAID Bethametasone |
| |
| Volatile anesthetics | Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Sevoflurane Propofol Remifentanil Oxycodone Paracetmol NSAID Bethametasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthesia depth monitoring | Procedure | Anesthesia depth monitoring during opioid-free anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient state index level (PSI) | Difference in PSI levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis | 20 minute during steady state peroperative anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Spectral edge frequency (SEF) | Difference in SEF levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis | 20 minute during steady state peroperative anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Density Spectral Array (DSA) | Descriptive comparison of DSA appearance during opioid-free anesthesia, target controlled and volatile anesthesia | 20 minute during steady state peroperative anesthesia |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing laparoscopic surgery under general anesthesia with different protocol-based anesthetic methods (opioid-free, intravenous target controlled or volatile) included after written and oral consent.
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| Name | Affiliation | Role |
|---|---|---|
| Krister Mogianos, MD | Region Halland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Halland Hospital Halmstad | Halmstad | Halland County | 30582 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39856547 | Derived | Mogianos K, Persson AK. Anesthesia depth monitoring during opioid free anesthesia - a prospective observational study. BMC Anesthesiol. 2025 Jan 24;25(1):37. doi: 10.1186/s12871-024-02859-1. |
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Project plan. Individual measurements. Statistical analysis.
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