UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes of airway protective function during recovery of general anesthesia
Title of the study (Brief title)	Recovery of general anesthesia and airway protective function
Region	Japan

Condition
Condition	Patients undergoing surgeries under general anesthesia
Classification by specialty	Gastroenterology Surgery in general Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test a hypothesis that neuromuscular antagonists reciver airway protective function during recovery from general anesthesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Barrier pressure (lower esophageal sphincter pressure minus gastric pressure)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of sugammadex
Interventions/Control_2	Intravenous administration of neostigmine
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	Female
Key inclusion criteria	Adult females undergoing surgeries under general anesthesia in Chiba University hospital
Key exclusion criteria	1) Patients with allergies for drugs used during anesthesia 2) Patients with severe co-morbidities 3) Patients with coagulopathy 4) Patients undergoing emergent surgery 5) Patients with full stomach 6) Patients who had upper gastrointestinal surgeries 7) Patients with GER 8) Obese patients with BMI greater than 30 kg/m2 9) Patients with renal dysfunction
Target sample size	20

Research contact person
Name of lead principal investigator	Teruhiko Ishikawa
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Anesthesiology
Address	1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL	043-222-7171
Email	tishikawa@faculty.chiba-u.jp

Public contact
Name of contact person	Shiroh Isono
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Anesthesiology
Address	1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL	043-222-7171
Homepage URL
Email	shirohisono@yahoo.co.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Grant from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 17 Day
Anticipated trial start date	2016 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 08 Day
Last modified on	2018 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023594