Trial Outcomes & Findings for Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients (NCT NCT01549873)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

at time of surgery

Results posted on

2015-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Total Intravenous Anesthesia (TIVA) propofol: Propofol adjusted to maintain the bispectral index at 40-60.	Inhaled Anesthesia Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Intravenous Anesthesia (TIVA) propofol: Propofol adjusted to maintain the bispectral index at 40-60.	Inhaled Anesthesia Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
Overall Study Physician Decision	0	1

Baseline Characteristics

Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Intravenous Anesthesia (TIVA) n=15 Participants propofol: Propofol adjusted to maintain the bispectral index at 40-60.	Inhaled Anesthesia n=15 Participants Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.5 years STANDARD_DEVIATION 2.1 • n=5 Participants	15.4 years STANDARD_DEVIATION 2.4 • n=7 Participants	14.9 years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: at time of surgery

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).

Outcome measures

Outcome measures
Measure	Total Intravenous Anesthesia (TIVA) n=15 Participants propofol: Propofol adjusted to maintain the bispectral index at 40-60.	Inhaled Anesthesia n=14 Participants Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
Amplitude Required to Elicit the MEP	307 milliamperes Standard Deviation 72	417 milliamperes Standard Deviation 82

SECONDARY outcome

Timeframe: day of surgery

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.

Outcome measures

Outcome measures
Measure	Total Intravenous Anesthesia (TIVA) n=15 Participants propofol: Propofol adjusted to maintain the bispectral index at 40-60.	Inhaled Anesthesia n=14 Participants Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
Amplitude of the SSEPs	0.83 microvolt Standard Deviation 0.4	0.84 microvolt Standard Deviation 0.25

SECONDARY outcome

Timeframe: day of surgery

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.

Outcome measures

Outcome measures
Measure	Total Intravenous Anesthesia (TIVA) n=15 Participants propofol: Propofol adjusted to maintain the bispectral index at 40-60.	Inhaled Anesthesia n=14 Participants Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
Latency of the SSEP's	27.6 milliseconds Standard Deviation 1.9	28.2 milliseconds Standard Deviation 2

Adverse Events

Total Intravenous Anesthesia (TIVA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inhaled Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Martin, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place