UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042156 |
|---|---|
| Receipt number | R000047980 |
| Scientific Title | The effect of anesthetic drugs on intraocular pressure during robot-assisted laparoscopic radical prostatectomy: comparison of remimazolam and desflurane |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2023/10/05 20:34:17 |
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Basic information
Public title
The effect of anesthetic drugs on intraocular pressure during robot-assisted laparoscopic radical prostatectomy: comparison of remimazolam and desflurane
Acronym
The effect of anesthetic drugs on intraocular pressure during robot-assisted laparoscopic radical prostatectomy: comparison of remimazolam and desflurane
Scientific Title
The effect of anesthetic drugs on intraocular pressure during robot-assisted laparoscopic radical prostatectomy: comparison of remimazolam and desflurane
Scientific Title:Acronym
The effect of anesthetic drugs on intraocular pressure during robot-assisted laparoscopic radical prostatectomy: comparison of remimazolam and desflurane
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effect of remimazolam and desflurane on intraocular pressure during robot-assisted laparoscopic radical prostatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in intraocular pressure during surgery
Key secondary outcomes
Mean arterial pressure
Peak inspiratory pressure
End-tidal CO2
Ocular perfusion pressure
Postoperative ocular complication
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
General anesthesia with remimazolam
Interventions/Control_2
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
Key inclusion criteria
1) Elective robot-assisted laparoscopic radical prostatectomy is scheduled.
2) American Society of Anesthesiologists physical status is either 1, 2, or 3.
Key exclusion criteria
1) Patients with a history of glaucoma
2) Patients with a history of myasthenia gravis
3) Patients with past or family history of malignant hyperthermia
4) Patients with corneal disease
5) Patients taking any medications which can alter intraocular pressure
6) Patients with allergy to study drugs
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroe |
| Middle name | |
| Last name | Shigeta |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
hiroe_y_0614@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Hiroe |
| Middle name | |
| Last name | Shigeta |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
hiroe_y_0614@hotmail.co.jp
Sponsor or person
Institute
National hospital organization Tokyo medical center
Institute
Department
Personal name
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
National hospital organization Tokyo medical center
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
Tel
03-3411-0111
215-rinri@mail.hosp.go.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
国立病院機構東京医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047980
