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Completed

NCT Number: NCT06227143

Anesthesia Depth During Opioid Free Anesthesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Halland Hospital Halmstad

Halmstad, Halland County, 30582, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Intolerance to NSAID

Treatment and study plan

Anesthesia depth monitoring

Procedure

Anesthesia depth monitoring during opioid-free anesthesia

Primary outcomes

  1. Patient state index level (PSI)

    Time frame: 20 minute during steady state peroperative anesthesia

    Difference in PSI levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis

Secondary outcomes

  1. Spectral edge frequency (SEF)

    Time frame: 20 minute during steady state peroperative anesthesia

    Difference in SEF levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis

Other outcomes

  1. Density Spectral Array (DSA)

    Time frame: 20 minute during steady state peroperative anesthesia

    Descriptive comparison of DSA appearance during opioid-free anesthesia, target controlled and volatile anesthesia

Sponsors and collaborators

Lead sponsor

Region Halland

Other

Registry information

Official study title

Monitoring Depth of Anesthesia During Opioid Free Anesthesia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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