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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020143
Receipt No. R000023266
Scientific Title Randomized controlled study for assessing effectiveness of hypercapnia on quality of emergence from general anesthesia in adults
Date of disclosure of the study information 2015/12/10
Last modified on 2018/05/31

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Basic information
Public title Randomized controlled study for assessing effectiveness of hypercapnia on quality of emergence from general anesthesia in adults
Acronym hypercapnia and quality of emergence from general anesthesia
Scientific Title Randomized controlled study for assessing effectiveness of hypercapnia on quality of emergence from general anesthesia in adults
Scientific Title:Acronym 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
1st name
Middle name
Last name Shiroh Isono
Organization Graduate School of Medicine, Chiba University
Division name Anesthesiology
Zip code
Address 1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL 043-22-7171
Email shirohisono@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiroh Isono
Organization Graduate School of Medicine, Chiba University
Division name Department of Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2015 Year 11 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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