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Comparison of the ED50 and ED95 of spinal hyperbaric ropivacanie in cesarean section between single and twin pregnancies: a dose-finding study

Comparison of the ED50 and ED95 of spinal hyperbaric ropivacanie in cesarean section between single and twin pregnancies: a dose-finding study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023104
Enrollment
Unknown
Registered
2019-05-11
Start date
2019-05-20
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

Combined spinal-epidural anesthesia for single and twin elective cesarean section

Interventions

Group A-1:Ropivacaine dose 9.5 mg
Group A-2:Ropivacaine dose 11mg
Group A-3:Ropivacaine dose 12.5mg
Group A-4:Ropivacaine dose 14mg
Group A-5:Ropivacaine dose 15.5mg
Group B-1:Ropivacaine dose 9.5 mg
Group B-2:Ropivacaine dose 11mg
Group B-3:Ropivacaine dose 12.5mg
Group B-4:Ropivacaine dose 14mg
Group B-5:Ropivacaine dose 15.5mg

Sponsors

Women’s Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for single pregnancy in group A were: (1) ASA2; (2) puerpera aged 18 to 40; (3) body weight (=110 kg), height (= 150 cm); (4) gestational weeks (= 37 weeks); (5) Selective single cesarean section. Inclusion criteria for twin pregnancy in group B were: (1) ASA2; (2) puerpera aged 18 to 40; (3) body weight (=110 kg), height (=150 cm); (4) gestational weeks (=34 weeks); (5) Selective twin cesarean section.

Exclusion criteria

Exclusion criteria: Exclusion criteria for single pregnancy in group A were: (1) contraindication of intraspinal anesthesia; (2) allergy to amide local anesthetics; (3) pregnancy induced hypertension or preeclampsia; (4) gestational diabetes; (5) asthma and heart diseases requiring treatment; (6) refusal to sign informed consent; (7) other conditions: ruptured membranes, active labor, twins and multiple pregnancy caesarean section. Uterine delivery, intrauterine growth restriction, placenta previa, fetal congenital abnormalities, etc. Exclusion criteria for twin pregnancy in group B were: (1) contraindication of intraspinal anesthesia; (2) allergy to amide local anesthetics; (3) severe pregnancy-induced hypertension or preeclampsia; (4) uncontrolled severe gestational diabetes; (5) asthma and heart diseases requiring treatment; (6) refusal to sign informed consent; (7) other conditions: ruptured membranes, active delivery Cheng, single, triplets and above cesarean section, intrauterine growth restriction, placenta previa, fetal congenital abnormalities, etc.

Design outcomes

Primary

MeasureTime frame
Successful rate of combined spinal-epidural anesthesia;

Secondary

MeasureTime frame
Sensory plane block;motor block;Pain score;General situation of pregnant women;Operation condition;Maternal vital signs;Umbilical Vein Blood Gas Analysis;Total placental weight;Total Birth Weight of Newborns;Neonatal Apgar Score;Adverse reactions such as hypotension;

Countries

China

Contacts

Public ContactXiaowei Qian

Department of Anesthesia, Women’s Hospital, Zhejiang University School of Medicine

qianxw@zju.edu.cn+86 15700157161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026