UMIN-CTR Clinical Trial

Basic information
Public title	An observational study examining relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade in surgical patients.
Acronym	Relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade
Scientific Title	An observational study examining relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade in surgical patients.
Scientific Title:Acronym	Relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade
Region	Japan

Condition
Condition	Patients undergoing surgery for intraabdominal malignancies
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery Obsterics and gynecology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Validation of accuracy of neuromuscular monitoring at m. orbiuclaris oculi during deep neuromuscular blockade
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation of the evoked response between m. abductor pollicis and m. orbicularis oculi during anesthesia
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing curative surgery for intraabdominal malignancies under general anesthesia
Key exclusion criteria	Patients who have known allergy to neuromuscular blocking agents. Patients who have known neuromuscular diseases.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshifumi Middle name Last name iKotake
Organization	Toho University Ohashi Medical Center
Division name	Department of Anesthesiology
Zip code	1538515
Address	2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL	03-3468-1251
Email	ykotake@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Kotake
Organization	Toho University Ohashi Medical Center
Division name	Department of Anesthesiology
Zip code	1538515
Address	2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL	03-3468-1251
Homepage URL
Email	ykotake@med.toho-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Toho University Ohashi Medical Center
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 Comittee of Toho University Ohashi Medical Center
Address	2-17-16, Ohashi, Meguro, Tokyo
Tel	0334681251
Email	secretary@oha.toho-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	2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	60
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Preparing presentation at scientific meeting
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	2016 Year 11 Month 25 Day
Date of IRB	2016 Year 04 Month 14 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 08 Month 31 Day

Other
Other related information	The observational study aims to determine the relationship between the twitch responses at two different monitoring sites ie, m. abductor pollicis and m. orbicularlis oculi in patients undergoing general surgery and administration of neuromuscular blocking agents.

Management information
Registered date	2016 Year 11 Month 27 Day
Last modified on	2019 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028772