UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravenous dexmedetomidine for cesarean section; randamized controlled trial
Title of the study (Brief title)	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	Manabu Yoshimura
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Department of Anesthesiology
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	Manabu Yoshimura
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029334