UMIN-CTR Clinical Trial

Basic information
Public title	Influence of opioid on the relationship between effect-site concentration of propofol at loss of response and that at maintenance of anesthesia
Acronym	Influence of opioid on the relationship between effect-site concentration of propofol at loss of response and that at maintenance of anesthesia
Scientific Title	Influence of opiod on effect of propofol
Scientific Title:Acronym	Influence of opiod on effect of propofol
Region	Japan

Condition
Condition	breast tumor and gall stone
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We previously showed that effect-site concentration of propofol at loss of response to verbal command (Ce-LOR) and that when EEG alpha power became maximum (Ce-alpha) were closely correlated. On the other hand, use of opioid such as fentanyl or remifentanil made Ce-LOR lower. Then we tried to clarify the effect of remifentanil on the relationship between Ce-LOR and Ce-alpha of propofol. Furthermore, we also tried to clarify the relationship between Ce-OBS (Ce at the onset of burst suppression) and them.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We investigate the relationship between Ce-LOR, Ce-alpha and Ce-OBS when effect-site concentration of remifentanil was kept 0, 0.1 or 0.2 ng/mL.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	No remifentanil is used.
Interventions/Control_2	Ce of remifentanil was controlled at 1.0 ng/mL.
Interventions/Control_3	Ce of remifentanil was controlled at 2.0 ng/mL.
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	Patinets who satisfied the following all conditions. 1) Age is 20 or more. 2) Hospitalized patient 3) both gender 4) ASA-PS is I or II 5) Low surgical stress 6) patients who scheduled lapaloscopic cholecystectcomy or mannmectomy 7) patients who agreed after informed consent
Key exclusion criteria	patients who matched either of following conditions. 1) patients who had severe liver dysfunction or severe renal dysfunction 2) pregnant or lactating women 3) patients who are medicated a drug that had interaction with propofol 4) patients who had neurological disorder 5) patients who showed allergy to propofol 6) ASA-PS III or more 7) obesity (BMI is 35 or more)
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Hagihira
Organization	Kansai Medical University
Division name	Department of Anesthesiology
Zip code	573-1191
Address	2-5-1 Shin-machi, Hirakata City
TEL	072-804-2683
Email	hagihirs@hirakata.kmu.a.cjp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Hagihira
Organization	Kansai Medical University
Division name	Department of Anesthesiology
Zip code	573-1191
Address	2-5-1 Shin-machi, Hirakata City
TEL	072-804-2683
Homepage URL
Email	hagihirs@hirakata.kmu.a.cjp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Departmential resources
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	Kansai Medical University center for ethical review
Address	2-5-1 Shin-machi, Hirakata City
Tel	072-804-2440
Email	rinriirb@hirakata.kmu.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	2020 Year 12 Month 20 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	No longer recruiting
Date of protocol fixation	2020 Year 11 Month 25 Day
Date of IRB	2020 Year 11 Month 25 Day
Anticipated trial start date	2020 Year 12 Month 20 Day
Last follow-up date	2023 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	2020 Year 12 Month 18 Day
Last modified on	2021 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048836