UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042380 |
|---|---|
| Receipt number | R000048348 |
| Scientific Title | Research for postoperative analgesia and nausea and vomiting after gynecological laparoscopic surgery |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2023/05/11 16:06:45 |
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Basic information
Public title
The postoperative analgesia of TAPA block and the comparison of the postoperative nausea and vomiting between remimazolam and propofol anesthesia in patients with gynecological laparoscopic surgery
Acronym
Research for postoperative analgesia and nausea and vomiting after gynecological laparoscopic surgery
Scientific Title
Research for postoperative analgesia and nausea and vomiting after gynecological laparoscopic surgery
Scientific Title:Acronym
Research for postoperative analgesia and nausea and vomiting in patients with gynecological laparoscopic surgery
Region
| Japan |
Condition
Condition
the patients who have laparoscopic ovariectomy or laparoscopic hysterectomy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The analgesia of TAPA block and postoperative nausea and vomiting with Remimazolam will be evaluated in comparison with the case of no block and the case of propofol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes: postoperative pain assessment during rest or movement (VAS), time to use additional analgesics after awakening, IVPCA bolus usage
Secondary outcomes: nausea, vomiting, antiemetics, presence of side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
intraoperative propofol
introduction: 1 mg/kg/hour
Maintenance: Start at 8 mg/kg/hour, increase or decrease as appropriate
TAPA block
Drugs: 0.25% levobupivacaine
Dosage: 20 ml
Interventions/Control_2
intraoperative remimazolam
introduction: 12 mg/kg/hour
Maintenance: Start at 1 mg/kg/hour, increase or decrease as appropriate
TAPA block
Drugs: 0.25% levobupivacaine
Dosage: 20 ml
Interventions/Control_3
intraoperative propofol
introduction: 1 mg/kg/hour
Maintenance: Start at 8 mg/kg/hour, increase or decrease as appropriate
no block
Interventions/Control_4
intraoperative remimazolam
introduction: 12 mg/kg/hour
Maintenance: Start at 1 mg/kg/hour, increase or decrease as appropriate
no block
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
Female
Key inclusion criteria
1) Patients over the age of 20
2) Patients who have laparoscopic oophorectomy, hysterectomy, and uterine enucleation
3) Patients who consented before surgery
Key exclusion criteria
Cases that fall under any of the following are not included in this study.
1) Patients under the age of 20
2) Patients with ASA classification 3 or higher
3) Patients with a history of hypersensitivity to the drugs used in this study, Patients with hypertension
4) Patients who are judged to be unsuitable by the doctor responsible for the research institution
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Unuma |
Organization
Akita University Graduate School of Medicine
Division name
Anesthesia and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita-city, Akita
TEL
018-884-6175
unuma18@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Unuma |
Organization
Akita University Graduate School of Medicine
Division name
Anesthesia and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita-city, Akita
TEL
018-884-6175
Homepage URL
unuma18@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
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
IRB
Address
1-1-1, Hondo, Akita-city, Akita
Tel
018-884-6216
soken@hos.akita-u.ac.jp
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
秋田大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048348
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
