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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020462
Receipt No. 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

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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
Email 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
Email imaizumi@kdu.ac.jp

Sponsor
Institute Department of Anesthesiology, Kanagawa Dental University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023641

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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