Opioid-free AnesthesiaNCT06227143
Anesthesia Depth During Opioid Free Anesthesia
An observational study of Opioid-free Anesthesia and Anesthesia Depth Monitoring, run by Region Halland at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-free Anesthesia, Anesthesia Depth Monitoring
- What is being tested?
- Anesthesia depth monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Elective laparoscopic surgery
- Adult patients
- Ability to accomodate verbal and written information in swedish
- Voluntary
Who cannot join
- Pregnancy
- Intolerance to NSAID
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Anesthesia depth monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia depth monitoringProcedure or surgery
Anesthesia depth monitoring during opioid-free anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Anesthesia depth monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient state index level (PSI)
Difference in PSI levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis
Measured: 20 minute during steady state peroperative anesthesia
Secondary outcomes (1)
Spectral edge frequency (SEF)
Difference in SEF levels during opioid-free anesthesia, target controlled and volatile anesthesia measured with Kruskal-Wallis
Measured: 20 minute during steady state peroperative anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Aug 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-free AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Halland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Persson, Region Halland
- Investigators
- Krister Mogianos, MD, Principal investigator, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227143
- Sponsor's protocol ID
- 2022-07156-02
- Status last verified
- Apr 2024
- First submitted
- 18 Jan 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Project plan. Individual measurements. Statistical analysis.
Publications
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.
PubMed 39856547
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Depth of Anesthesia During Opioid Free Anesthesia
- ClinicalTrials.gov ID
- NCT06227143
- Acronym / sponsor ID
- 2022-07156-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region HallandUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opioid-free anesthesia | – | Procedure: Anesthesia depth monitoringPatients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Ketamine Dexmedetomidine Propofol Sevoflurane Lidocaine Betamethasone Paracetamol NSAID |
| Target Controlled Infusion | – | Procedure: Anesthesia depth monitoringPatients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Propofol Remifentanil Oxycodone Paracetamol NSAID Bethametasone |
| Volatile anesthetics | – | Procedure: Anesthesia depth monitoringPatients undergoing laparoscopic surgery under general anesthesia. Drugs used for the purpose of anesthesia: Sevoflurane Propofol Remifentanil Oxycodone Paracetmol NSAID Bethametasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Elective laparoscopic surgery
- Adult patients
- Ability to accomodate verbal and written information in swedish
- Voluntary
Key exclusion criteria (2 listed)
- Pregnancy
- Intolerance to NSAID
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia depth monitoringAnesthesia depth monitoring during opioid-free anesthesia | Procedure or surgery | Opioid-free anesthesia, Target Controlled Infusion, Volatile anesthetics |
Primary outcome
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
1 secondary outcome
Spectral edge frequency (SEF)
Time frame: 20 minute during steady state peroperative anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 39856547Mogianos 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.
- Individual participant dataSharing planned: Undecided. Project plan. Individual measurements. Statistical analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krister Mogianos, MD principal investigator
Region Halland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-free Anesthesia and Anesthesia Depth Monitoring, run by Region Halland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient state index level (PSI) (time frame: 20 minute during steady state peroperative anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.