Scoliosis Clinical Trial
— SCOLOfficial 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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients indicated for scoliosis surgery with perioperative MEP monitoring Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Faculty hospital Brno | Brno | Jihomoravský Kraj |
Lead Sponsor | Collaborator |
---|---|
Brno University Hospital |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Perioperative blood management | blood loss, blood derivates and transfusion products administered to the patient in first 24 hours after surgery | 24 hours postoperatively | |
Other | Surgical complications | Neurological complications and number of surgical revisions within 30 days and length of days of hospitalization will be recorded. | 30 days postoperatively | |
Other | Anaesthesiology management data | Surgery length, the interval between the end of surgery to extubation. | Intraoperative period until extubation | |
Primary | 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. | During the scoliosis surgery | |
Secondary | 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. | During the scoliosis surgery |
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