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.

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. - Prospective evaluation of circulatory dynamics of preoperative oral rehydration therapy targeted at scheduled cesarean section using PVI (Pleth Variability Index) as an indicator.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023471

Enrollment

Registered

2016-08-05

Start date

2017-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scheduled cesarean section (ASA 1 or 2) for previous ceasarean section, previous obstetric surgery or plevis position.

Interventions

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 ope

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactTomoyuki Sato

saiseikai yokohamashi tobu hospital department of anesthesiology

tomoyukisatoh@seagreen.ocn.ne.jp045-576-3000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026