UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045905 |
|---|---|
| Receipt number | R000052349 |
| Scientific Title | Recovery of sedation and psychomotor and equilibrium functions following remimazolam anesthesia with or without flumazenil |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2023/05/01 21:16:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Recovery of sedation and psychomotor and equilibrium functions following remimazolam anesthesia with or without flumazenil
Acronym
Recovery of sedation and psychomotor and equilibrium functions following remimazolam anesthesia with or without flumazenil
Scientific Title
Recovery of sedation and psychomotor and equilibrium functions following remimazolam anesthesia with or without flumazenil
Scientific Title:Acronym
Recovery of sedation and psychomotor and equilibrium functions following remimazolam anesthesia with or without flumazenil
Region
| Japan |
Condition
Condition
Patients undergoing dental treatment under general anesthesia
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the recovery process of sedation and psychomotor and equilibrium functions after remimazolam anesthesia with and without flumazenil.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before anesthesia and 30, 60, 90, 120 minutes after extubation, psychomotor function is examined and compared with Digit Symbol Substitution Test and Trieger dot test, and equilibrium function is examined and compared with Timed Up & Go Test and Center of gravity sway test.
Sedation level is assessed using the MOA/S score every minute after administration of flumazenil or saline.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antagonist use group.
5 minutes after the end of surgery, administer 2 ml of flumazenil.
Interventions/Control_2
Antagonist non-use group.
5 minutes after the end of surgery, administer 2 ml of physiological saline.
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA-PS I or II patients (18-64 years old) scheduled for minimally invasive surgery in the outpatient department of dental anesthesiology.
Key exclusion criteria
Those with ASA-PS III or higher, those who have difficulty in securing the airway due to micrognathism, trismus, extreme obesity, etc., those who are thought to have gastric contents, major invasive surgery or long-term treatment, postoperative Cases with expected complications (bleeding or swelling), emergency surgery, patients with infection, those who have difficulty communicating, those with unilateral overgrowth, etc. Persons, persons taking benzodiazepine anxiolytics, persons under the age of 18
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | kyotaro |
| Middle name | |
| Last name | koshika |
Organization
Tokyo dental college
Division name
Department of Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Kanda Misaki, Chiyoda, Tokyo
TEL
03-6380-9113
koshikakyotarou@tdc.ac.jp
Public contact
Name of contact person
| 1st name | kyotaro |
| Middle name | |
| Last name | koshika |
Organization
Tokyo dental college
Division name
Department of Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Kanda Misaki, Chiyoda, Tokyo
TEL
03-6380-9113
Homepage URL
koshikakyotarou@tdc.ac.jp
Sponsor or person
Institute
Tokyo dental college
Institute
Department
Personal name
Funding Source
Organization
Tokyo dental college
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
Tokyo dental college
Address
2-9-18 Kanda Misaki, Chiyoda, Tokyo
Tel
03-6380-9113
koshikakyotarou@tdc.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 28 | 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
88
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
| 2021 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052349
