UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The adjunct analgesic effect of metoclopramide for the intraoperative caesarean section patients by combined spinal epidural anesthesia (CSEA).
Title of the study (Brief title)	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	Otoya Yoshimoto
Organization	Kagoshima city hospital
Division name	Department of anesthesiology
Address	20-17,Kajiya-cho,Kagoshima-shi,Kagosima,Japan
TEL	099-224-2101
Email	oyoshi-kago@umin.org

Public contact
Name of contact person	Otoya Yoshimoto
Organization	Kagoshima city hospital
Division name	Department of anesthesiology
Address	20-17,Kajiya-cho,Kagoshima-shi,Kagosima,Japan
TEL	099-224-2101
Homepage URL
Email	oyoshi-kago@umin.org

Sponsor
Institute	Department of anesthesiology, Kagoshima city hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012180