Clinical trial NCT06227143: Anesthesia Depth During Opioid Free Anesthesia
Official title: Monitoring Depth of Anesthesia During Opioid Free Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-free Anesthesia
Anesthesia Depth Monitoring
Lead sponsor: Region Halland
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic surgery
* Adult patients
* Ability to accomodate verbal and written information in swedish
* Voluntary

Exclusion Criteria:

* Pregnancy
* Intolerance to NSAID

Primary outcomes:
measure: Patient state index level (PSI)
timeFrame: 20 minute during steady state peroperative anesthesia
Secondary outcomes:
measure: Spectral edge frequency (SEF)
timeFrame: 20 minute during steady state peroperative anesthesia
Other outcomes:
measure: Density Spectral Array (DSA)
timeFrame: 20 minute during steady state peroperative anesthesia
Locations:
city: Halmstad
country: Sweden
facility: Halland Hospital Halmstad
state: Halland
Study officials:
affiliation: Region Halland
name: Krister Mogianos, MD
role: PRINCIPAL_INVESTIGATOR
References: