UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039101 |
|---|---|
| Receipt number | R000044594 |
| Scientific Title | The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2021/01/02 18:43:55 |
* 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
The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Acronym
The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Scientific Title
The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Scientific Title:Acronym
The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of the partial antagonist effect of pentazocine in reducing respiratory depression induced by remifentanil.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect that pentazocine has on respiratory depression induced by remifentanil.
Key secondary outcomes
Side effects of pentazocine.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Use pentazocine.
Interventions/Control_2
Not use pentazocine.
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients scheduled for elective surgery requiring general anesthesia.
ASA-PS 1-2
Key exclusion criteria
ASA-PS >=3
Tha patients who are diagnosised or suspected sleep apnea syndrome
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Chikubu |
Organization
Matsudo city general hospital
Division name
Anesthesiology
Zip code
2702252
Address
993-1,Sendabori,Matsudo-shi,Chiba
TEL
0477122511
higuneko1@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Chikubu |
Organization
Matsudo city general hospital
Division name
Anesthesiology
Zip code
2702252
Address
993-1,Sendabori,Matsudo-shi,Chiba
TEL
0477122511
Homepage URL
higuneko1@yahoo.co.jp
Sponsor or person
Institute
Matsudo city general hospital
Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Matsudo city hospital network Institutional review board
Address
993-1,Sendabori,Matsudo-shi,Chiba
Tel
0477122511
higuneko1@yahoo.co.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
| 2020 | Year | 01 | Month | 10 | 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
10
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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044594
