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Anesthesia Depth During Opioid Free Anesthesia

Monitoring Depth of Anesthesia During Opioid Free Anesthesia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06227143
Enrollment
30
Registered
2024-01-26
Start date
2023-08-01
Completion date
2024-02-01
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Depth Monitoring, Opioid-free Anesthesia

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.

Interventions

PROCEDUREAnesthesia depth monitoring

Anesthesia depth monitoring during opioid-free anesthesia

Sponsors

Region Halland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pregnancy * Intolerance to NSAID

Design outcomes

Primary

MeasureTime frameDescription
Patient state index level (PSI)20 minute during steady state peroperative anesthesiaDifference in PSI levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis

Secondary

MeasureTime frameDescription
Spectral edge frequency (SEF)20 minute during steady state peroperative anesthesiaDifference in SEF levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis

Other

MeasureTime frameDescription
Density Spectral Array (DSA)20 minute during steady state peroperative anesthesiaDescriptive comparison of DSA appearance during opioid-free anesthesia, target controlled and volatile anesthesia

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026