UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020462 |
|---|---|
| Receipt number | R000023641 |
| Scientific Title | Comparison of the recovery of function after general anesthesia with sevoflurane or desflurane |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2019/07/10 12:55:16 |
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Basic information
Public title
Comparison of the recovery of function after general anesthesia with sevoflurane or desflurane
Acronym
The recovery of function after general anesthesia with sevoflurane or desflurane
Scientific Title
Comparison of the recovery of function after general anesthesia with sevoflurane or desflurane
Scientific Title:Acronym
The recovery of function after general anesthesia with sevoflurane or desflurane
Region
| Japan |
Condition
Condition
Patients undergoing oral surgery with general anesthesia
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The utility of sevoflurane and desflurane is compared from the postoperative recovery of function and respiratory complications risk about the patient by whom an oral surgery operation was carried out under the general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EtCO2 after extubation, at the time of the exit, and after returning the ward
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
We randomly assign 22 patients who undergo General anesthesia with sevoflurane.
Interventions/Control_2
We randomly assign 22 patients who undergo General anesthesia with desflurane.
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
Male and Female
Key inclusion criteria
Patients who are American Society of Anesthesiologists Physical Status 1 or 2 and scheduled for oral surgery under general anesthesia
Key exclusion criteria
1. ASA-PS 3 or 4
2. patient with respiratory disease
3. smoker
4. patient with sleep apnea syndrome
5. patient with micrognathia
6. patient with trismus
7. patient with short neck
8. patient with Mallampati classification 3 and 4
9. patient with obesity
10. patient who has a history of difficult airway management
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uno Imaizumi |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology
Zip code
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
046-822-8842
imaizumi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uno Imaizumi |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology
Zip code
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
046-822-8842
Homepage URL
imaizumi@kdu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 06 | Day |
Last modified on
| 2019 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023641
