UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled study for assessing effectiveness of hypercapnia on quality of emergence from general anesthesia in adults
Title of the study (Brief title)	hypercapnia and quality of emergence from general anesthesia
Region	Japan

Condition
Condition	Adult patients undergoing abdominal sugeries under general anesthesia combined with epidural anesthesia
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test a hypothesis that hypercapnia shortens emergence from general anesthesia and stabilizes cardio-respiratory functions, and to explore interactions between consciousness level and cardio-respiratory functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	emergence time from cessation of general anesthetics
Key secondary outcomes	Critical cardio-respiratory events

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	normocapnia: ET-CO2 30-35 mmHg is maintained until emergence from anesthesia.
Interventions/Control_2	hypercapnia: ET-CO2 is gradually reduced from 60-65 mmHg until emergence from anesthesia
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients scheduled for invasive arterial blood pressure monitoring 2. Patients scheduled for general anesthesia combined with epidural anesthesia 3. Patients undergoing abdominal surgeries
Key exclusion criteria	1. Patients with ASA (American Society of Anesthesiologists) physical status greater than 3 2. Patients with abnormal upper airway 3. Patients with asthma 4. Patients with post-head and neck surgeries 5. Patients with COPD (%FEV1.0<70%) 6. Patients with tracheostomy 7. Patients with intra-cranial pathologies 8. Patients with hypoxemia at emergence from anesthesia 9. Patients without indication for extubation in the operating room
Target sample size	50

Research contact person
Name of lead principal investigator	Shiroh Isono
Organization	Graduate School of Medicine, Chiba University
Division name	Anesthesiology
Address	1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL	043-22-7171
Email	shirohisono@yahoo.co.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	Chiba University Hospital
Institute
Department

Funding Source
Organization	Japanese grant-in-aid (4390363) from the Ministry of Education, Culture, Sports, Science and Technology
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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 17 Day
Anticipated trial start date	2015 Year 12 Month 15 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	2015 Year 12 Month 10 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023266