Anesthesia Depth During Opioid Free Anesthesia

NCT ID: NCT06227143

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-02-01

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.

Conditions

Opioid-free Anesthesia; Anesthesia Depth Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Anesthesia depth monitoring

Intervention Type: PROCEDURE

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

Anesthesia depth monitoring

Intervention Type: PROCEDURE

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

Anesthesia depth monitoring

Intervention Type: PROCEDURE

Anesthesia depth monitoring during opioid-free anesthesia

Interventions

Anesthesia depth monitoring

Anesthesia depth monitoring during opioid-free anesthesia

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Halland

OTHER

Sponsor Role: lead

Responsible Party

Anna Persson

MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krister Mogianos, MD

Role: PRINCIPAL_INVESTIGATOR

Region Halland

Locations

Halland Hospital Halmstad

Halmstad, Halland County, Sweden

Countries

Sweden

References

Mogianos K, Persson AK. Anesthesia depth monitoring during opioid free anesthesia - a prospective observational study. BMC Anesthesiol. 2025 Jan 24;25(1):37. doi: 10.1186/s12871-024-02859-1.

Reference Type: DERIVED

PMID: 39856547 (View on PubMed)

Other Identifiers

2022-07156-02

Identifier Type: -

Identifier Source: org_study_id