Anesthesia Depth During Opioid Free Anesthesia

Monitoring Depth of Anesthesia 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.

Study Overview

• Status: Completed
• Conditions: Opioid-free Anesthesia; Anesthesia Depth Monitoring
• Intervention / Treatment: Procedure: Anesthesia depth monitoring

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Sweden
  • Halland
    • Halmstad, Halland, Sweden, 30582
      • Halland Hospital Halmstad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy
• Intolerance to NSAID

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Anesthesia depth monitoring; Anesthesia depth monitoring during opioid-free anesthesia
Target Controlled Infusion; Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Propofol Remifentanil Oxycodone Paracetamol NSAID Bethametasone	Procedure: Anesthesia depth monitoring; Anesthesia depth monitoring during opioid-free anesthesia
Volatile anesthetics; Patients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Sevoflurane Propofol Remifentanil Oxycodone Paracetmol NSAID Bethametasone	Procedure: Anesthesia depth monitoring; Anesthesia depth monitoring during opioid-free anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Region Halland
• Investigators: Principal Investigator: Krister Mogianos, MD, Region Halland

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2022-07156-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Project plan. Individual measurements. Statistical analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No