UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025489
Receipt No. 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

* 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 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
Obsterics 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
Email 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
Email manabu-ygc@umin.ac.jp

Sponsor
Institute Department of Anesthesiology, Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.