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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023471
Receipt No. R000027045
Scientific Title Open lavel single center randomized parallel group trial concerning circulatory dynamics evaluation using PVI (Pleth Variability Index) between preoperative oral rehydration therapy group and prohibited preoperative eating and drinking group targeted at ASA 1or 2 of scheduled cesarean section for previous cesarean section, previous obstetric surgery or plevis position.
Date of disclosure of the study information 2016/08/05
Last modified on 2018/09/08

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Basic information
Public title Open lavel single center randomized parallel group trial concerning circulatory dynamics evaluation using PVI (Pleth Variability Index) between preoperative oral rehydration therapy group and prohibited preoperative eating and drinking group targeted at ASA 1or 2 of scheduled cesarean section for previous cesarean section, previous obstetric surgery or plevis position.
Acronym Prospective evaluation of circulatory dynamics of preoperative oral rehydration therapy targeted at scheduled cesarean section using PVI (Pleth Variability Index) as an indicator.
Scientific Title Open lavel single center randomized parallel group trial concerning circulatory dynamics evaluation using PVI (Pleth Variability Index) between preoperative oral rehydration therapy group and prohibited preoperative eating and drinking group targeted at ASA 1or 2 of scheduled cesarean section for previous cesarean section, previous obstetric surgery or plevis position.
Scientific Title:Acronym Prospective evaluation of circulatory dynamics of preoperative oral rehydration therapy targeted at scheduled cesarean section using PVI (Pleth Variability Index) as an indicator.
Region
Japan

Condition
Condition Scheduled cesarean section (ASA 1 or 2) for previous ceasarean section, previous obstetric surgery or plevis position.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our goal in this study is to provide safer and more comfortable perioperative care for scheduled low risk cesarean section through verification of effectiveness of preoperative oral rehydration therapy and of pleth variability index (PVI) which indicator of Radical 7.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1. The incidense of hypotension
The definition of hypotension is systolic blood pressure of no more than 90mmHg or of systolic blood pressure decrease not less than 20%. The evaluation period is from the entrance to operating room till the birth of baby.
Key secondary outcomes 1. Pleth variability index at the entrance to operating room.
2. The change of pleth variability index from the previous night to the entrance to operating room.
3. The change of pleth variability index after the birth of baby between the sedation case and the non sedation case
4. Intraoperative urinary output
5. Apgar score (1min. 5min.)
6. Umbitical arterial blood gasanalysis (pH, PaCO2, PaO2, BS, Na, K)
7. Transition of blood glucose level within 24hour after the birth.
8. The satisfaction of the patient. (Numeric Rating Scale)
9. The incidense of nausea and vomiting.
10. The incidense of other side effects.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients are prohibited eating from 9 p.m.of the previous night of cesarean section. OS-1 1500ml is delivered personally and instructed to drink sparely at least 500ml by two hours before entering operation room. PVI before start to drinking of OS1 is measured.
After entering operating room, patient is monitered ECG NIBP SpO2 temperature and Masimo Radical 7 PVI. Each of data is recorded throughout operation. 20G catheter is placed in a forearm vein. After administration of normal saline of 100ml with antibiotics, HES 130/0.4/9 (6%) is started. Epidural anaesthesia and spinal anaesthesia are performed in the lateral position. Epidural catheter is placed at the T10/11 or T11/12 vertebral interspace and test dose is notconducted. Spinal anaesthesia is performed at the L2/3 or L3/4 vertebral interspace, hyperbalic 0.5% bupivacaine 10mg and fentanyl 0.02mg is injected through a 25G Quincke needle. Oxygenation is started via facemask by 5l/min after returning to the supine position.
Noninvasive blood pressure is checked every 1 min until delivery. The upper sensory block level is checked after 10min of spinal anaesthesia using alcohol cottons. The definition of hypotension is systolic blood pressure of no more than 90mmHg or of systolic blood pressure decrease not less than 20%. Hypotension is treated with 50ml bolus of HES 130/0.4/9 (6%) and phenylephrine 0.1mg if HR is no less than 60/min, and with 50ml bolus of HES 130/0.4/9 (6%) and ephedrine 0.1mg if HR is no less than 60/min.
Refractoly bradycardia regardless of using ephedrine is treated with 0.5mg of atropin. Postpartum nausea or vomiting is treated with 1.25mg of droperidol. Blood gas analysis of umbilical vein is performed after delivery. If the patient wishes to sedate after birth, propofol is administered using TCI pump and BIS monitor. BIS target is about 70.
Urinary output is measured and the upper sensory block level is checked after surgery. Blood sugar of neonate within 24 hours is measured.
Interventions/Control_2 Patients are prohibited eating and drinking from 9 p.m.of the previous night of ceasarean section. PVI at rest of the previous night of operation is measured.
After entering operating room, patient is monitered ECG NIBP SpO2 temperature and Masimo Radical 7 PVI. Each of data is recorded throughout operation. 20G catheter is placed in a forearm vein. After administration of normal saline of 100ml with antibiotics, HES 130/0.4/9 (6%) is started. Epidural anaesthesia and spinal anaesthesia are performed in the lateral position. Epidural catheter is placed at the T10/11 or T11/12 vertebral interspace and test dose is notconducted. Spinal anaesthesia is performed at the L2/3 or L3/4 vertebral interspace, hyperbalic 0.5% bupivacaine 10mg and fentanyl 0.02mg is injected through a 25G Quincke needle. Oxygenation is started via facemask by 5l/min after returning to the supine position.
Noninvasive blood pressure is checked every 1 min until delivery. The upper sensory block level is checked after 10min of spinal anaesthesia using alcohol cottons. The definition of hypotension is systolic blood pressure of no more than 90mmHg or of systolic blood pressure decrease not less than 20%. Hypotension is treated with 50ml bolus of HES 130/0.4/9 (6%) and phenylephrine 0.1mg if HR is no less than 60/min, and with 50ml bolus of HES 130/0.4/9 (6%) and ephedrine 0.1mg if HR is no less than 60/min.
Refractoly bradycardia regardless of using ephedrine is treated with 0.5mg of atropin. Postpartum nausea or vomiting is treated with 1.25mg of droperidol. Blood gas analysis of umbilical vein is performed after delivery. If the patient wishes to sedate after birth, propofol is administered using TCI pump and BIS monitor. BIS target is about 70.
Urinary output is measured and the upper sensory block level is checked after surgery. Blood sugar of neonate within 24 hours is measured.
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
45 years-old >=
Gender Female
Key inclusion criteria 1.ASA 1or 2 of scheduled ceasarean section for previous ceasarean section or plevis position after the 37th week of gestation and under the age of 45.
2.Weight from 45kg to 90kg
3.Fully apprehended as to purport or meaning of the study and with written consent (approved by the ethics committee) after received an explanation.
Key exclusion criteria 1.Allergic or having contraindication to any medicine used in this study
2.Pregnancy induced hypertension
3.Multiple pregnancy
4.abnormal fetus
5.Diabetic(HbA1c>7)
6.Cardiovascular or cerebrovascular disorder
7.Coagulopathy disorder
8.neuromuscular disease
9.BMI>35
10.Renal impairment(estimated Ccr<30)

Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Sato
Organization saiseikai yokohamashi tobu hospital
Division name department of anesthesiology
Zip code
Address 3-6-1 shimosueyoshi turumi-ku yokohama-shi kanagawa-ken
TEL 045-576-3000
Email tomoyukisatoh@seagreen.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Sato
Organization saiseikai yokohamashi tobu hospital
Division name department of anesthesiology
Zip code
Address 3-6-1 shimosueyoshi turumi-ku yokohama-shi kanagawa-ken
TEL 045-576-3000
Homepage URL
Email tomoyukisatoh@seagreen.ocn.ne.jp

Sponsor
Institute saiseikai yokohamashi tobu hospital
Institute
Department

Funding Source
Organization saiseikai yokohamashi tobu 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 08 Month 05 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
2019 Year 07 Month 15 Day
Date trial data considered complete
2019 Year 07 Month 30 Day
Date analysis concluded
2019 Year 08 Month 15 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027045

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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