UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025489 |
|---|---|
| Receipt number | R000029334 |
| Scientific Title | Intravenous dexmedetomidine for cesarean section; randamized controlled trial |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2019/01/07 09:49:03 |
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Basic information
Public title
Intravenous dexmedetomidine for cesarean section; randamized controlled trial
Acronym
DEX_CS_RCT
Scientific Title
Intravenous dexmedetomidine for cesarean section; randamized controlled trial
Scientific Title:Acronym
DEX_CS_RCT
Region
| Japan |
Condition
Condition
patient undergoing cesarean section
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dexmedetomidine is a central alfa2-adrenoreceptor agonist that exerts superior sedative and analgesic effects. We propose that it can intraoperatively and postoperatively suppress the pain associated with uterine contractions and the visceral pain that occurs between the extraction of the foetus and closure of the surgical incision during cesarean sections. Jessen et al. indicated that perioperative DEX for acute pain after abdominal surgery in adults decreases postoperative surgical pain. Similarly, Nie et al. reported that intravenous DEX infusion was useful to decrease postoperative surgical pain of cesarean section performed under spinal anesthesia.We aim to obtain the efficacy of intravenous DEX for ceasarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
7-point Likert-like verbal rating scale for assessment of patients satisfaction with intraoperative sedation analgesia
Key secondary outcomes
QoR-40
nausea and vomiting
effective time for spinal anesthesia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DEX6 microg/kg/hr at 10 minutes, and 0.4 microg/kg/hr
Interventions/Control_2
normal 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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
1)elective patients undergoing epidural and spinal anesthesia
2)Provided written informed consent to undergo the procedure.
Key exclusion criteria
1)emergency
2)severe complication
3)intraoperative massive bleeding
4)refusal
5)obesity
6)a congenital disease has already known
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan
TEL
0834-28-4411
manabu-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan
TEL
0834-28-4411
Homepage URL
manabu-ygc@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Japan Community Healthcare Organization Tokuyama Central Hospital
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
| 2016 | Year | 12 | Month | 31 | 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
| 2016 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 31 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029334
