UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033068
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

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Basic information

Public title

Effects of low dose droperidol on transcranial electrical motor-evoked potentials.

Acronym

Effects of low dose droperidol on transcranial electrical motor-evoked potentials.

Scientific Title

Effects of low dose droperidol on transcranial electrical motor-evoked potentials.

Scientific Title:Acronym

Effects of low dose droperidol on transcranial electrical motor-evoked potentials.

Region

Japan


Condition

Condition

Idiopathic scoliosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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.

Key secondary outcomes

MEP amplitude from other muscles, latency of SSEP and MEP, amplitude of evoked electromyography (M wave, H wave, F wave).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

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.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

12 years-old <=

Age-upper limit

20 years-old >=

Gender

Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Baba

Organization

Niigata University Medical & Dental Hospital

Division name

Division of Anesthesiology

Zip code

951-8520

Address

1-754, Asahimachi-Street, Chuo-ku, Niigata Citiy, Niigata

TEL

025-227-2328

Email

masui@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Mitsuma

Organization

Niigata University Medical & Dental Hospital

Division name

Division of Anesthesiology

Zip code

951-8520

Address

1-754, Asahimachi-Street, Chuo-ku, Niigata Citiy, Niigata

TEL

070-5562-4404

Homepage URL


Email

y.mikan.mikan.mikan@gmail.com


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Review Committee for Humans

Address

1-757, Asahimachi-Street, Chuo-ku, Niigata Citiy, Niigata

Tel

025-227-2005

Email

ethics@adm.niigata-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 01 Day


Related information

URL releasing protocol

https://niigata.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=2309

Publication of results

Published


Result

URL related to results and publications

https://journals.lww.com/jnsa/Abstract/9000/Low_dose_Droperidol_Reduces_the_Amplitude_of.98971.aspx

Number of participants that the trial has enrolled

20

Results

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.

Results date posted

2022 Year 02 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

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.

Adverse events

No patients exhibited any adverse events such as extrapyramidal symptoms, arrhythmias, and intraoral injuries requiring treatment.

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 06 Month 18 Day

Date of IRB

2018 Year 06 Month 18 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2019 Year 08 Month 28 Day

Date of closure to data entry

2019 Year 10 Month 10 Day

Date trial data considered complete

2019 Year 10 Month 10 Day

Date analysis concluded

2020 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2018 Year 06 Month 20 Day

Last modified on

2022 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037701


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name