UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034168
Receipt number R000038951
Scientific Title The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery
Date of disclosure of the study information 2018/09/18
Last modified on 2021/09/24 10:40:25

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Basic information

Public title

The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery

Acronym

The effect of desflurane on motor evoked potential

Scientific Title

The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery

Scientific Title:Acronym

The effect of desflurane on motor evoked potential

Region

Japan


Condition

Condition

Patients with ASA status 1 or 2, who are more than or equal to 20 years old and undergo spine surgery under motor evoked potential (MEP) monitoring

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the suppressive effects of desflurane and propofol on MEP, and demonstrate the safety of desflurane in adult patienst undergoing spine surgery

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The intensity of electronic stimulation at first MEP evaluation

Key secondary outcomes

MEP amplitude at first evaluation
The intensity of electronic stimulation and MEP amplitude after first MEP evaluation
The frequency of MEP amplitude reduction or disappearance after first MEP evaluation
The number of patients who presented MEP reduction or disappearance during operation and paralysis after operation
Time to extubation from the end of surgery


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intervention:
General anesthesia using desflurane(0.5-1.5MAC)

Interventions/Control_2

Control:
General anesthesia using propofol(Target controlled infusion:1.5 -4.0 microgram/ml)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with ASA status 1 or 2, who are more than or equal to 20 years old and undergo spine surgery

Key exclusion criteria

Patients with past history or family history of malignant hyperthermia
Patients with allergy to desflurane or propofol
Patients with paralysis of upper or lower limbs before surgery

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Morisaki

Organization

Keio University School of Medicine

Division name

Department of Anesthesiology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email

morisaki@z8.keio.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Suzuki

Organization

Tokai University School of Medicine

Division name

Department of Anesthesiology

Zip code

259-1193

Address

143 Shimokasuya, Isehara, Kanagawa, Japan

TEL

0463-93-1121

Homepage URL


Email

takeshi-su@a7.keio.jp


Sponsor or person

Institute

Department of Anesthesiology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee, Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-5363-3611

Email

med-rinri-jimu@adst.keio.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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2018 Year 08 Month 30 Day

Date of IRB

2018 Year 09 Month 08 Day

Anticipated trial start date

2018 Year 09 Month 19 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 16 Day

Last modified on

2021 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038951


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name