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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000041337
Receipt No. R000047150
Scientific Title Incidence of respiratory depression associated with administration of intrathecal opioid for cesarean delivery: A randomized controlled trial.
Date of disclosure of the study information 2020/08/07
Last modified on 2020/12/16

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Basic information
Public title Incidence of respiratory depression associated with administration of intrathecal morphine for cesarean delivery
Acronym Respiratory depression associated with administration of intrathecal morphine for cesarean delivery
Scientific Title Incidence of respiratory depression associated with administration of intrathecal opioid for cesarean delivery: A randomized controlled trial.
Scientific Title:Acronym Respiratory depression associated with administration of intrathecal opioid for cesarean delivery
Region
Japan

Condition
Condition cesarean delivery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate respiratory depression induced by intrathecal opioid for cesarean delivery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate hypoxia events after cesarean delivery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Intrathecal morphine 50 microgram
Interventions/Control_2 Intrathecal morphine 100 microgram
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. Patients with elective cesarean delivery
under spinal anesthesia
2. American Society of Anesthesiologists
physical status: 2-3
3. The patient is over 20 years old.
4. Obtaining consent form from patients
Key exclusion criteria 1 Emergency surgery
2 Patients with allergy including
fentanyl, morphine and local anesthetic
3 Patient who already have respiratory complications
4 Patients with obesity (BMI>30)
5 Patients with sleep apnea syndrome
6 Patients with hypertension
7 Patients who have been using opioids
for a long time

Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Kushizaki
Organization National Hospital Organization Hamada
Medical Center
Division name Department of Anesthesiology
Zip code 697-8511
Address 777-12 Asaicho Hamada, Shimane
TEL 0855-25-0505
Email kushizaki.hiroyuki.mw@mail.hosp.go.jp

Public contact
Name of contact person
1st name Noritaka
Middle name
Last name Imamachi
Organization Shimane University
Division name Department of Anesthesiology
Zip code 693-8501
Address 89-1 Enyacho Izumo, Shimane
TEL 0853-20-2295
Homepage URL
Email imamachi@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Shimane University
Name of secondary funder(s)

IRB Contact (For public release)
Organization The National Hospital Organization Hamada Medical Center Institutional Committee on Ethics
Address 777-12 Asaicho Hamada, Shimane
Tel 0855-25-0505
Email None

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
2020 Year 08 Month 07 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
2020 Year 06 Month 19 Day
Date of IRB
2020 Year 06 Month 19 Day
Anticipated trial start date
2020 Year 08 Month 03 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 06 Day
Last modified on
2020 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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