UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023471 |
|---|---|
| Receipt number | 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 05:52:29 |
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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
| Obstetrics 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
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
tomoyukisatoh@seagreen.ocn.ne.jp
Sponsor or person
Institute
saiseikai yokohamashi tobu hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027045
