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Recruitment status Completed
Unique ID issued by UMIN UMIN000011466
Receipt No. R000013420
Scientific Title Analysis of incidence of postoperative nausea and vomiting after oral surgery with desflurane
Date of disclosure of the study information 2013/08/19
Last modified on 2015/05/13

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Basic information
Public title Analysis of incidence of postoperative nausea and vomiting after oral surgery with desflurane
Acronym Analysis of incidence of postoperative nausea and vomiting after oral surgery with desflurane
Scientific Title Analysis of incidence of postoperative nausea and vomiting after oral surgery with desflurane
Scientific Title:Acronym Analysis of incidence of postoperative nausea and vomiting after oral surgery with 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 To disclose incidence of postoperative nausea and vomiting after surgery with desflurane
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative nausea and vomiting within 24 hours after operation
Key secondary outcomes Time to extubation from end of operation, time to emergence from the anesthetic dosage end and time to recovering orientation from emergence

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 inhalation of 4-5% desflurane during general anesthesia
Interventions/Control_2 inhalation of 1-2% sevoflurane during general 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria patients who are American Society of Anesthesiologists Physical Status 1 or 2 and scheduled for operation required approximately 1-2 hours under general anesthesia
Key exclusion criteria patients with ischemic heart disease
patients with hepatic or renal dysfunction
patients with histry of or family histry of malignant hyperthermia
contraindication for propofol,sevoflurane and deslurane
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aiji Boku
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthsiology
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2972
Email bokuaiji@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aiji Boku
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthsiology
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2972
Homepage URL
Email bokuaiji@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Osaka University Graduate School of Dentistry
Organization
Division
Category of Funding Organization Other
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
2013 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 19 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
2013 Year 08 Month 12 Day
Last modified on
2015 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013420


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