UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043648
Receipt number R000049843
Scientific Title Respiratory depression after cesarean delivery1 under spinal anesthesia: Prospective cohort study.
Date of disclosure of the study information 2021/03/19
Last modified on 2021/03/19 16:09:27

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Basic information

Public title

Respiratory depression after cesarean delivery1 under spinal anesthesia.



Acronym

Respiratory depression after cesarean delivery1 under spinal anesthesia.

Scientific Title

Respiratory depression after cesarean delivery1 under spinal anesthesia: Prospective cohort study.

Scientific Title:Acronym

Respiratory depression after cesarean delivery1 under spinal anesthesia.

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 spinal anesthesia after cesarean delivery.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate hypoxia events 24h after cesarean delivery.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

60


Research contact person

Name of lead principal investigator

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

Email

imamachi@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Masato
Middle name
Last name HIrabayashi

Organization

The

Division name

Department of Anesthesiology

Zip code

693-8501

Address

89-1 Enyacho Izumo, Shimane

TEL

0853-20-2295

Homepage URL


Email

shimane29@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology, Shimane University

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Shimane University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Hospital Organization Hamada
Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Shimane University Institutional Committee on Ethics

Address

89-1 Enyacho Izumo, Shimane

Tel

0853-20-2515

Email

kenkyu@med.shimane-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

5336

Org. issuing International ID_1

The Shimane University Institutional Committee on Ethics

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 19 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

Preinitiation

Date of protocol fixation

2021 Year 03 Month 17 Day

Date of IRB


Anticipated trial start date

2021 Year 03 Month 25 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective cohort study


Management information

Registered date

2021 Year 03 Month 17 Day

Last modified on

2021 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049843


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name