UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013884 |
|---|---|
| Receipt number | R000013913 |
| Scientific Title | Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV |
| Date of disclosure of the study information | 2014/05/03 |
| Last modified on | 2017/05/08 09:49:19 |
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Basic information
Public title
Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Acronym
Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Scientific Title
Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Scientific Title:Acronym
Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Region
| Japan |
Condition
Condition
womem schedulled for cesarean section using combined spinal-epidural anesthesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate pentazocine in patients subject to cesarean section for the prophylactic effect on the postoperative pruritus, nausea and vomiting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative pain, postoperative pruritus, PONV,
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
pentazocin 15mg iv
Interventions/Control_2
normal saline 1ml iv
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
ASA1-2 patients undergoing elective cesarean section using combined spinal-epidural anesthesia
Key exclusion criteria
emergency cases, ASA PS more than 3, coagulation disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsushi Doi |
Organization
Hamada Medical Center
Division name
Anesthesiology
Zip code
Address
777-12 Asai-cho, Hamada, Shimane
TEL
0855-25-0505
kdoiepi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsushi Doi |
Organization
Hamada Medical Center
Division name
Anesthesiology
Zip code
Address
777-12 Asai-cho, Hamada, Shimane
TEL
0855-25-0505
Homepage URL
kdoiepi@gmail.com
Sponsor or person
Institute
Hamada Medical Center Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hamada Medical Center Department of Anesthesiology
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
| 2014 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013913
