Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients

Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia

When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital the investigators typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.

Study Overview

• Status: Completed
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Drug: propofol; Drug: Desflurane

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with idiopathic scoliosis.

Exclusion Criteria:

• Patients with neuromuscular scoliosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Total intravenous anesthesia (TIVA)	Drug: propofol; Propofol adjusted to maintain the bispectral index at 40-60.; Other Names: Diprivan
ACTIVE_COMPARATOR: Inhaled anesthesia	Drug: Desflurane; Desflurane adjusted to maintain the bispectral index at 40-60.; Other Names: Suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude Required to Elicit the MEP	Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).	at time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of the SSEPs	SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. The amplitude is the voltage of the electrical stimulation recorded.	day of surgery
Latency of the SSEP's	SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. Latency is the time interval between the stimulation and response.	day of surgery

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (ESTIMATE): March 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Desflurane
• Other Study ID Numbers: IRB11-00727