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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01549873
Other study ID # IRB11-00727
Secondary ID
Status Completed
Phase N/A
First received March 7, 2012
Last updated February 24, 2015
Start date January 2012
Est. completion date June 2013

Study information

Verified date February 2015
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with idiopathic scoliosis.

Exclusion Criteria:

- Patients with neuromuscular scoliosis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
propofol
Propofol adjusted to maintain the bispectral index at 40-60.
Desflurane
Desflurane adjusted to maintain the bispectral index at 40-60.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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