Blood Propofol Concentrations in Children During Spinal Surgery

Status Completed

Clinical Trial Summary

During major spinal surgery evoked potential monitoring is performed to detect spinal cord damage. Intra-venous anaesthesia is the preferred anaesthetic technique because volatile anaesthetic agents supress the evoked potentials. Total Intra-Venous Anaesthesia (TIVA) with propofol is commonly administered as a Target Controlled Infusion (TCI). The TCI is an automated drug delivery system which administers propofol to achieve a desired blood concentration, based on an in built pharmaco-kinetic data (TCI model) derived from previous studies. The TCI model also provides a real time predicted blood concentration to facilitate the anaesthetist to adjust the target concentration of propofol.

The TCI algorithm is based on pharmaco-kinetic data derived from previous studies in a relatively small number of patients, by a "best fit" relationship between blood levels, infusion rates and other factors (such as age and weight). Several factors make it possible for a wide discrepancy between the predicted and the true blood concentrations. This difference can be higher in children compared to adults. Also blood loss and administration of large volumes of intravenous fluids can affect the blood concentrations. This study aims to identify the difference between the predicted and true blood concentrations by using Pelorus 1500, a bedside blood propofol measurement device, in children undergoing major spinal surgery under TIVA.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01932424
Study type	Interventional
Source	Great Ormond Street Hospital for Children NHS Foundation Trust
Contact
Status	Completed
Phase	Phase 4
Start date	January 2013
Completion date	July 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01795495` - Methadone vs Magnesium in Spinal Fusion	Phase 2
Recruiting	`NCT04539522` - Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis	N/A
Recruiting	`NCT05128279` - Adolescent and Young Adulte Scoliosis
Withdrawn	`NCT04633031` - The Effect of Bracing on Sagittal Balance in Scoliosis
Recruiting	`NCT03978273` - Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients	N/A
Recruiting	`NCT06161038` - Precision Medicine for Nociception, Sngception and Proprioception.	N/A
Not yet recruiting	`NCT06055140` - Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis
Active, not recruiting	`NCT05001568` - Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis	N/A
Terminated	`NCT03663088` - Effect of Global Postural Re-education in Idiopathic Scoliosis	N/A
Recruiting	`NCT05575596` - Influence of Social Deprivation and Remoteness on Quality of Life in Adolescent's Surgical Scoliosis
Completed	`NCT04714632` - Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis
Not yet recruiting	`NCT05347056` - The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area in Adolescent Idiopathic Scoliosis
Completed	`NCT05333796` - The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography	N/A
Completed	`NCT03190668` - Skeletal Muscle and Adipose Tissue Study	Phase 4
Completed	`NCT03209752` - Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
Active, not recruiting	`NCT02651324` - Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis	Phase 4
Completed	`NCT01019109` - Scoliosis Surgery Using the PASS® LP System
Not yet recruiting	`NCT06298812` - REFLECT Scoliosis System Post Approval Study	N/A
Recruiting	`NCT06331143` - Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion	N/A
Completed	`NCT05095129` - The Role of Genetic Factors in the Development of Idiopathic Scoliosis in the Kazakh Population