ScoliosisSCOLNCT04423146
Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
An observational study of Scoliosis, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Alteration of evoked potentials is described in cases with using inhalation anaesthetics. Muscle relaxants are contraindicated in case of motor evoked potentials except for initial dose for intubation of the patient. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- The evocation of reproducible motor evoked potential according to the different BIS levels
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2020to 1 Jan 2025
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients indicated for elective scoliosis surgery with perioperative MEP monitoring
Who may be able to join
- Patients indicated for scoliosis surgery with perioperative MEP monitoring
Who cannot join
- Scoliosis surgery without perioperative MEP monitoring
- Contraindication for perioperative MEP monitoring
- Contraindication of using propofol (soy, egg lecithin or peanuts allergy,...) or other drugs used for anaesthesia
- The inability of attachment of BIS electrodes to the standard position
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Faculty hospital Brno
Brno, South Moravian, 62500
Martina Kosinova, MD., Ph.D., 532234692 ext. 00420, kosinova.martina@fnbrno.cz
Jan Hudec, MD., 532233852 ext. 00420, hudec.jan@fnbrno.cz
About this study
Official title: Advanced Methods for Improving Anesthesiologic Management and Their Effect on Perioperative Outcome in Scoliosis Surgery, Especially in Childhood (SCOL Study): a Prospective Observational Study
Alteration of evoked potentials is described in cases with using inhalation anaesthetics. Muscle relaxants are contraindicated in case of motor evoked potentials except for initial dose for intubation of the patient. Dominant anaesthetic method for procedures with measuring motor evoked potentials is total intravenous anaesthesia (TIVA). Bispectral index (BIS) monitoring is one of the possible options for comprehensive monitoring of the depth of general anaesthesia. It helps to optimize the management of anaesthesia, so it reduces the risk of perioperative awakenings due to shallow anaesthesia or inadequate depth of anaesthesia associated with the risk of cognitive dysfunction, as well as investigators expect worse interpretation of motor evoked potentials. At the same time, it shortens the time to wake up from general anaesthesia after hours-long surgery. BIS monitoring allows optimizing the depth of anaesthesia and leads to improve quality and interpretation of motor evoked potentials. The depth of TIVA managed by BIS affects the reproducibility of motor evoked potentials.
Read the detailed description
SCOL study is designed as a prospective observational study. We will monitor patients with scoliosis suitable for TIVA with BIS monitoring after the approval by the ethical committee of the University Hospital Brno and the Faculty of Medicine of Masaryk University in Brno, Czech Republic. The study period is planned from 1st September 2020 to 31st December 2024. Anaesthesia will be maintained following standardized local protocol for scoliosis surgery, include preoperative preparation and premedication. General anaesthesia will be performed in TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor evoked potentials will be measured and evaluated by members of operating team perioperatively. The evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored. Motor evoked potentials (MEP) reproducibility will be based on standardized orthopaedic practice, according to the amplitude, latency of the MEP. The reproducibility will be monitored in defined surgery phases: before skin incision at the different BIS levels, next after screw application, rod applications, after distraction and the last one before wound suturing. At the same time, the BIS value is recorded.
In addition to the MEP reproducibility, investigators will measure the amplitude and latency value. These parameters and actual BIS value will be monitored in each patient after the recovery from neuromuscular blockade (TOF ratio value above 90%) to eliminate the influence of neuromuscular blockade on neurophysiology monitoring. Due to individual variability in the MEP latency and amplitude in these patients, the initial MEP value will be set as the default (100%), and other values will be expressed as a percentage.
Other monitored parameters in this study will be blood loss, blood derivates and transfusion products administered to the patient in first 24 hours after surgery, the time between the end of the surgery and extubation, neurological complications, number of surgical revisions and a total length of hospitalization.
The annual number of scoliosis operations at the University hospital Brno is around 130 patients. It is the largest surgery centre in Central Europe.
- Conditions
- Scoliosis
- Being tested
- The evocation of reproducible motor evoked potential according to the different BIS levels
- Keywords
- scoliosis, surgery, scoliosis surgery, Motor evoked potentials
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The evocation of reproducible motor evoked potential according to the different BIS levelsOther
The evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for elective scoliosis surgery | Patients scheduled for elective scoliosis surgery will be anesthetized in TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor evoked potentials will be measured and evaluated by members of operating team perioperatively. The quality of evoked potentials (poor vs good quality) and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored. Receives: Other: The evocation of reproducible motor evoked potential according to the different BIS levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60)
The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60) will be monitored according to standardized orthopaedic practise for evaluation of MEP.
Measured: During the scoliosis surgery
Secondary outcomes (1)
MEP parameters
MEP parameters (latency and amplitude) parameters will be monitored in defined surgery phases with recording the actual MEP values and BIS value after recovery from neuromuscular blockade. The initial MEP value will be set as the default (100%), and other values will be expressed as a percentage. We will analyze scoliosis subgroups, the idiopathic and neuromuscular scoliosis.
Measured: During the scoliosis surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Repko Martin, prof. MD., Ph.D., Study chair, Faculty of medicince Masaryk University and University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423146
- Sponsor's protocol ID
- SCOL 2020
- Acronym
- SCOL
- Status last verified
- Mar 2023
- First submitted
- 5 Jun 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Methods for Improving Anesthesiologic Management and Their Effect on Perioperative Outcome in Scoliosis Surgery, Especially in Childhood (SCOL Study): a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04423146
- Acronym / sponsor ID
- SCOL / SCOL 2020
- Conditions
- Scoliosis
- Keywords
- scoliosis, surgery, scoliosis surgery, Motor evoked potentials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 9 Jun 2020 (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.
Alteration of evoked potentials is described in cases with using inhalation anaesthetics. Muscle relaxants are contraindicated in case of motor evoked potentials except for initial dose for intubation of the patient. Dominant anaesthetic method for procedures with measuring motor evoked potentials is total intravenous anaesthesia (TIVA). Bispectral index (BIS) monitoring is one of the possible options for comprehensive monitoring of the depth of general anaesthesia. It helps to optimize the management of anaesthesia, so it reduces the risk of perioperative awakenings due to shallow anaesthesia or inadequate depth of anaesthesia associated with the risk of cognitive dysfunction, as well as investigators expect worse interpretation of motor evoked potentials. At the same time, it shortens the time to wake up from general anaesthesia after hours-long surgery. BIS monitoring allows optimizing the depth of anaesthesia and leads to improve quality and interpretation of motor evoked potentials. The depth of TIVA managed by BIS affects the reproducibility of motor evoked potentials.
Detailed description
SCOL study is designed as a prospective observational study. We will monitor patients with scoliosis suitable for TIVA with BIS monitoring after the approval by the ethical committee of the University Hospital Brno and the Faculty of Medicine of Masaryk University in Brno, Czech Republic. The study period is planned from 1st September 2020 to 31st December 2024. Anaesthesia will be maintained following standardized local protocol for scoliosis surgery, include preoperative preparation and premedication. General anaesthesia will be performed in TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor evoked potentials will be measured and evaluated by members of operating team perioperatively. The evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored. Motor evoked potentials (MEP) reproducibility will be based on standardized orthopaedic practice, according to the amplitude, latency of the MEP. The reproducibility will be monitored in defined surgery phases: before skin incision at the different BIS levels, next after screw application, rod applications, after distraction and the last one before wound suturing. At the same time, the BIS value is recorded.
In addition to the MEP reproducibility, investigators will measure the amplitude and latency value. These parameters and actual BIS value will be monitored in each patient after the recovery from neuromuscular blockade (TOF ratio value above 90%) to eliminate the influence of neuromuscular blockade on neurophysiology monitoring. Due to individual variability in the MEP latency and amplitude in these patients, the initial MEP value will be set as the default (100%), and other values will be expressed as a percentage.
Other monitored parameters in this study will be blood loss, blood derivates and transfusion products administered to the patient in first 24 hours after surgery, the time between the end of the surgery and extubation, neurological complications, number of surgical revisions and a total length of hospitalization.
The annual number of scoliosis operations at the University hospital Brno is around 130 patients. It is the largest surgery centre in Central Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for elective scoliosis surgery | – | Other: The evocation of reproducible motor evoked potential according to the different BIS levelsPatients scheduled for elective scoliosis surgery will be anesthetized in TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor evoked potentials will be measured and evaluated by members of operating team perioperatively. The quality of evoked potentials (poor vs good quality) and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients indicated for elective scoliosis surgery with perioperative MEP monitoring
Key inclusion criteria (1 listed)
- Patients indicated for scoliosis surgery with perioperative MEP monitoring
Key exclusion criteria (4 listed)
- Scoliosis surgery without perioperative MEP monitoring
- Contraindication for perioperative MEP monitoring
- Contraindication of using propofol (soy, egg lecithin or peanuts allergy,...) or other drugs used for anaesthesia
- The inability of attachment of BIS electrodes to the standard position
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 |
|---|---|---|
| The evocation of reproducible motor evoked potential according to the different BIS levelsThe evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored. | Other | Patients scheduled for elective scoliosis surgery |
Primary outcome
The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60)
Time frame: During the scoliosis surgery
The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60) will be monitored according to standardized orthopaedic practise for evaluation of MEP.
1 secondary outcome
MEP parameters
Time frame: During the scoliosis surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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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.
Repko Martin, prof. MD., Ph.D. study chair
Faculty of medicince Masaryk University and University Hospital Brno
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 Scoliosis, run by Brno University Hospital at 1 site in Czechia.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Kosinova, MD., Ph.D (532234692 ext. 00420, kosinova.martina@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60) (time frame: During the scoliosis surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2023.