Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery

NCT04423146 | Unknown DMC

• 1 other identifier: SCOL 2020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Scoliosis

Keywords

scoliosis; surgery; scoliosis surgery; Motor evoked potentials

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MEP parameters

  During the scoliosis surgery

Other Outcomes (3)

• Perioperative blood management

  24 hours postoperatively

• Surgical complications

  30 days postoperatively

• Anaesthesiology management data

  Intraoperative period until extubation

Study Arms (1)

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.

Other: The evocation of reproducible motor evoked potential according to the different BIS levels

Interventions

The evocation of reproducible motor evoked potential according to the different BIS levels OTHER

The evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored.

Patients scheduled for elective scoliosis surgery

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for elective scoliosis surgery with perioperative MEP monitoring

You may qualify if:

• Patients indicated for scoliosis surgery with perioperative MEP monitoring

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Faculty hospital Brno

Brno, South Moravian, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Repko Martin, prof. MD., Ph.D.

  Faculty of medicince Masaryk University and University Hospital Brno

  STUDY CHAIR

Central Study Contacts

Martina Kosinova, MD., Ph.D

CONTACT

532234692; kosinova.martina@fnbrno.cz

Jan Hudec, MD.

CONTACT

532233852; hudec.jan@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc.prof.MD,Ph.D

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CZ (1)