UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034688 |
|---|---|
| Receipt number | R000037587 |
| Scientific Title | postoperative nausea and vomiting after gynecologic hysteroscopic surgery on propofol and remifentanil total intravenous anesthesia (tiva) vs. desflurane and remifentanil anesthesia; prospective, randomized, double-blinded, control study |
| Date of disclosure of the study information | 2018/10/30 |
| Last modified on | 2018/10/29 19:36:42 |
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Basic information
Public title
postoperative nausea and vomiting after gynecologic hysteroscopic surgery on propofol and remifentanil total intravenous anesthesia (tiva) vs. desflurane and remifentanil anesthesia; prospective, randomized, double-blinded, control study
Acronym
Comparing the effect on postoperative nausea and vomming, between propofol/remifentanil anesthesia and desuflurane/remifentanil anesthesia
Scientific Title
postoperative nausea and vomiting after gynecologic hysteroscopic surgery on propofol and remifentanil total intravenous anesthesia (tiva) vs. desflurane and remifentanil anesthesia; prospective, randomized, double-blinded, control study
Scientific Title:Acronym
Comparing the effect on postoperative nausea and vomming, between propofol/remifentanil anesthesia and desuflurane/remifentanil anesthesia
Region
| Japan |
Condition
Condition
women who undertake hysteroscopic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
propofol/remifentanil anesthesia reduces the incidence and the degree of postoperative nausea and vommiting, compared with desflurane/remifentanil anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of post operative nausea and vomiting and the degree of it
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
general anesthesia with propofol/remifentanil TIVA
Interventions/Control_2
general anesthesia with Desflurane/remifentanil
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
ASA PS 1 or 2, non-pregnant female patients who undergo trans corporeal resection
Key exclusion criteria
BMI >=30 kg/m2, treated with psychoactive drags, too much alcohol intake, allergy with drags used in this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Ohokubo Hospital
Division name
Anesthesiology
Zip code
Address
2-44-1 Kabuki-cho, Shinjyuku-ku, Tokyo 160-8488 Japan
TEL
03-5273-7111
suguru-.-yamamoto@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Ohokubo Hospital
Division name
Anesthesiology
Zip code
Address
2-44-1 Kabuki-cho, Shinjyuku-ku, Tokyo 160-8488 Japan
TEL
03-5273-7111
Homepage URL
suguru-.-yamamoto@hotmail.co.jp
Sponsor or person
Institute
Ohokubo Hospital IRB
Institute
Department
Personal name
Funding Source
Organization
Ohokubo Hospital
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
| 2018 | Year | 10 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 20 | 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
| 2018 | Year | 10 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037587
