Skip to main content
Clinical Trials/NCT06227143
NCT06227143
Completed
Not Applicable

Monitoring Depth of Anesthesia During Opioid Free Anesthesia

Region Halland1 site in 1 country30 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid-free Anesthesia
Sponsor
Region Halland
Enrollment
30
Locations
1
Primary Endpoint
Patient state index level (PSI)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Persson

MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine

Region Halland

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

Outcomes

Primary Outcomes

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

  • Spectral edge frequency (SEF)(20 minute during steady state peroperative anesthesia)

Study Sites (1)

Loading locations...

Similar Trials