Unique ID issued by UMIN | UMIN000033068 |
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Receipt number | R000037701 |
Scientific Title | Effects of low dose droperidol on transcranial electrical motor-evoked potentials. |
Date of disclosure of the study information | 2018/07/01 |
Last modified on | 2022/02/18 13:16:04 |
Effects of low dose droperidol on transcranial electrical motor-evoked potentials.
Effects of low dose droperidol on transcranial electrical motor-evoked potentials.
Effects of low dose droperidol on transcranial electrical motor-evoked potentials.
Effects of low dose droperidol on transcranial electrical motor-evoked potentials.
Japan |
Idiopathic scoliosis
Orthopedics |
Others
NO
We study the effect of low dose droperidol on transcranial electrical motor-evoked potentials [MEP].
Low dose droperidol is often administered during surgery to prevent postoperative nausea and vomiting. Recently, a case report was reported that transcranial electrical motor-evoked potentials amplitude decreased with administration of low dose of droperidol. Also, in the retrospective analysis at our institution, it was found that the MEP amplitude decreased after using the low dose droperidol. We planned this study in order to prevent post operative nausea and vomiting and increase the accuracy of intra-operative neurologic monitoring by rethinking the timing of administration of droperidol.
Efficacy
The amplitude of the motor-evoked potentials obtained from the left tibialis anterior muscle in the low dose droperidol administration group and saline administration group.
MEP amplitude from other muscles, latency of SSEP and MEP, amplitude of evoked electromyography (M wave, H wave, F wave).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
First we measure the control amplitude of the MEP. Next, 20 microgram per kilogram of DROLEPTAN INJECTION is administered. Measure MEP every 2 minutes for 10 minutes. After 10 minutes, measure SSEP, M wave, H wave, F wave. After completion of recording, saline is administered.
First we measure the control amplitude of the MEP. Next, saline is administered. Measure MEP every 2 minutes for 10 minutes. After 10 minutes, measure SSEP, M wave, H wave, F wave. After completion of recording, 20 microgram per kilogram of DROLEPTAN INJECTION is administered.
12 | years-old | <= |
20 | years-old | >= |
Female
The subjects were female patients aged 12 to 20 who were scheduled to perform corrective surgery for idiopathic scoliosis, which requires the intraoperative MEP measurement of ASA 1-2.
Those with the following disorders in the past history; convulsive seizures, epilepsy, intracranial diseases, neuromuscular diseases, extrapyramidal diseases, peripheral nerve diseases, severe cardiovascular lesions, prolonged QT syndrome, hepatic dysfunction, renal dysfunction , Mental illness and mental retardation
Beta blockade or MAO inhibitor is administered.
What can not understand the purpose of this research.
Those with hypersensitivity to the components of the drug to be used.
Those weighing less than 30 kg.
Other, exclude those who judge it as inappropriate for this research.
20
1st name | Hiroshi |
Middle name | |
Last name | Baba |
Niigata University Medical & Dental Hospital
Division of Anesthesiology
951-8520
1-754, Asahimachi-Street, Chuo-ku, Niigata Citiy, Niigata
025-227-2328
masui@med.niigata-u.ac.jp
1st name | Yusuke |
Middle name | |
Last name | Mitsuma |
Niigata University Medical & Dental Hospital
Division of Anesthesiology
951-8520
1-754, Asahimachi-Street, Chuo-ku, Niigata Citiy, Niigata
070-5562-4404
y.mikan.mikan.mikan@gmail.com
Niigata University
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
Research Ethics Review Committee for Humans
1-757, Asahimachi-Street, Chuo-ku, Niigata Citiy, Niigata
025-227-2005
ethics@adm.niigata-u.ac.jp
NO
2018 | Year | 07 | Month | 01 | Day |
https://niigata.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=2309
Published
https://journals.lww.com/jnsa/Abstract/9000/Low_dose_Droperidol_Reduces_the_Amplitude_of.98971.aspx
20
The minimum relative TCE-MEP amplitude of the left TA was 37% [30% to 55%] of the baseline value in the droperidol group (n=10) and 76% [58% to 93%] of the baseline value in the saline group (n=8) (P<0.01). There were no statistically significant differences in the bilateral APB and left QF. In the other muscles, bolus administration of droperidol (20 ug/kg) reduced the relative amplitude of TCE-MEP by 32% to 49% of the baseline value in each muscle.
2022 | Year | 02 | Month | 18 | Day |
After obtaining written informed consent from the patients and their guardians, we recruited female patients aged 12 to 20 who were scheduled to undergo posterior spinal fusion for adolescent idiopathic scoliosis between July 2018 and September 2019.
orty patients were assessed for eligibility; 20 were excluded. Twenty consecutive patients were randomly allocated to the droperidol group or saline group. One patient in the saline group was excluded without receiving an intervention due to mechanical failure after the allocation. There were no other dropouts, and a total of 19 patients were included finally. The baseline characteristics were comparable between the groups.
No patients exhibited any adverse events such as extrapyramidal symptoms, arrhythmias, and intraoral injuries requiring treatment.
The minimum relative TCE-MEP amplitude of the left TA was 37% [30% to 55%] of the baseline value in the droperidol group (n=10) and 76% [58% to 93%] of the baseline value in the saline group (n=8) (P<0.01). There were no statistically significant differences in the bilateral APB and left QF. In the other muscles, bolus administration of droperidol (20 ug/kg) reduced the relative amplitude of TCE-MEP by 32% to 49% of the baseline value in each muscle. The relative amplitude of the left H-reflex and bilateral F waves recorded from the GC were lower in the droperidol group compared to those in the saline group. There were no significant differences in the relative onset latencies or relative amplitudes of the other evoked potentials. There were no significant differences in the hemodynamic parameters after the administration of droperidol or saline.
Completed
2018 | Year | 06 | Month | 18 | Day |
2018 | Year | 06 | Month | 18 | Day |
2018 | Year | 07 | Month | 01 | Day |
2019 | Year | 08 | Month | 28 | Day |
2019 | Year | 10 | Month | 10 | Day |
2019 | Year | 10 | Month | 10 | Day |
2020 | Year | 04 | Month | 01 | Day |
2018 | Year | 06 | Month | 20 | Day |
2022 | Year | 02 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037701
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