UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020143 |
|---|---|
| Receipt number | 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 05:32:28 |
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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
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
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023266
