UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000023641