Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery (SCOL)

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis
• Intervention / Treatment: Other: The evocation of reproducible motor evoked potential according to the different BIS levels

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Martina Kosinova, MD., Ph.D; Phone Number: 00420 532234692; Email: kosinova.martina@fnbrno.cz
• Study Contact Backup: Name: Jan Hudec, MD.; Phone Number: 00420 532233852; Email: hudec.jan@fnbrno.cz

Study Locations

• Czechia
  • Jihomoravský Kraj
    • Brno, Jihomoravský Kraj, Czechia, 62500
      • Recruiting
      • Faculty Hospital Brno
      • Contact: Jan Hudec, MD.; Phone Number: 00420 532233852; Email: hudec.jan@fnbrno.cz
      • Contact: Martina Kosinova, MD., Ph.D.; Phone Number: 00420 532234692; Email: kosinova.martina@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for elective scoliosis surgery with perioperative MEP monitoring

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative blood management	blood loss, blood derivates and transfusion products administered to the patient in first 24 hours after surgery	24 hours postoperatively
Surgical complications	Neurological complications and number of surgical revisions within 30 days and length of days of hospitalization will be recorded.	30 days postoperatively
Anaesthesiology management data	Surgery length, the interval between the end of surgery to extubation.	Intraoperative period until extubation

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Study Chair: Repko Martin, prof. MD., Ph.D., Faculty of medicince Masaryk University and University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: surgery; scoliosis; scoliosis surgery; Motor evoked potentials
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: SCOL 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No