NCT06227143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

January 18, 2024

Last Update Submit

April 9, 2024

Conditions

Opioid-free AnesthesiaAnesthesia Depth Monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Spectral edge frequency (SEF)

    20 minute during steady state peroperative anesthesia

Other Outcomes (1)

  • Density Spectral Array (DSA)

    20 minute during steady state peroperative anesthesia

Study Arms (3)

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

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

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

Interventions

Anesthesia depth monitoringPROCEDURE

Anesthesia depth monitoring during opioid-free anesthesia

Opioid-free anesthesiaTarget Controlled InfusionVolatile anesthetics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Intolerance to NSAID

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halland Hospital Halmstad

Halmstad, Halland County, 30582, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 39856547DERIVED

Study Officials

  • Krister Mogianos, MD

    Region Halland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 26, 2024

Study Start

August 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

SE(1)