UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010456 |
|---|---|
| Receipt number | R000012180 |
| Scientific Title | The adjunct analgesic effect of metoclopramide for the intraoperative caesarean section patients by combined spinal epidural anesthesia (CSEA). |
| Date of disclosure of the study information | 2013/04/10 |
| Last modified on | 2016/10/13 12:37:34 |
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Basic information
Public title
The adjunct analgesic effect of metoclopramide for the intraoperative caesarean section patients by combined spinal epidural anesthesia (CSEA).
Acronym
The adjunct analgesic effect of metoclopramide for the intraoperative caesarean section patients by combined spinal epidural anesthesia (CSEA).
Scientific Title
The adjunct analgesic effect of metoclopramide for the intraoperative caesarean section patients by combined spinal epidural anesthesia (CSEA).
Scientific Title:Acronym
The adjunct analgesic effect of metoclopramide for the intraoperative caesarean section patients by combined spinal epidural anesthesia (CSEA).
Region
| Japan |
Condition
Condition
Women being to undergo elective caesarean section by combined spinal epidural anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing metoclopramide injected preemptively as an analgesic adjunct for intraoperative caesarean section patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence or absence of pain in intraoperative patients. In the case of pain, the time from starting spinal anesthesia to appearance of the pain, degree of the pain (Numeric Rating Scale: 0~10), anesthetic level checked by using ice.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Immediately after fetus delivery, we give normal saline (2ml) intravenously.
Interventions/Control_2
Immediately after fetus delivery, we give metoclopramide (10mg/2ml) intravenously.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
ASA physical status 1 or 2, women being to undergo elective caesarean section by combined spinal epidural anesthesia.
Key exclusion criteria
Asthma.
Hyper obesity (BMI over 35).
ASA physical status 3 or higher.
Other additional operations except tubal ligation.
Operation more than 2 hours.
Using a sadative agent or an additional analgesic agent before appearance of pain.
Using metoclopramide before appearance of pain in normal saline group.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Otoya Yoshimoto |
Organization
Kagoshima city hospital
Division name
Department of anesthesiology
Zip code
Address
20-17,Kajiya-cho,Kagoshima-shi,Kagosima,Japan
TEL
099-224-2101
oyoshi-kago@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Otoya Yoshimoto |
Organization
Kagoshima city hospital
Division name
Department of anesthesiology
Zip code
Address
20-17,Kajiya-cho,Kagoshima-shi,Kagosima,Japan
TEL
099-224-2101
Homepage URL
oyoshi-kago@umin.org
Sponsor or person
Institute
Department of anesthesiology, Kagoshima city hospital
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
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
| 2013 | Year | 04 | 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
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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2016 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012180
