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ED90 of phenylephrine to prevent spinal anesthesia-induced hypotension during elective cesarean section in the supine position——An Up-Down Sequential Allocation Dose-Response Study

ED90 of phenylephrine to prevent spinal anesthesia-induced hypotension during elective cesarean section in the supine position——An Up-Down Sequential Allocation Dose-Response Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120008
Enrollment
Unknown
Registered
2026-03-07
Start date
2026-03-08
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Spinal anesthesia-induced hypotension

Interventions

Supine Dose-Escalation Cohort:Up-and-down sequential dose-response trial: Each subject received prophylactic phenylephrine after anesthesia positioning. Initial dose 40µg, subsequent doses adjusted ba
if ineffective, increase by 10µg) until ED90 dose was determined. All subjects received standard preloading (10mL/kg lactated Ringer's solution).

Sponsors

Shanghai First Maternal and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in the study: All parturients signed informed consent forms. 2. Planned elective cesarean section under spinal anesthesia. 3. Single fetus, gestational age >37 weeks. 4. ASAI or grade II. 5. 18 years < age <45 years

Exclusion criteria

Exclusion criteria: 1. Height 100 kg, or body mass index (BMI)>35 kg/m^2 2. Allergy to norepinephrine 3. Chronic hypertension during pregnancy, gestational hypertension, preeclampsia, eclampsia, and pregnancy-related heart disease 4. Fetal distress, or other fetal abnormalities 5. Supine position syndrome in late pregnancy 6. Contraindications for intrathecal anesthesia: such as coagulation disorders, local anesthetic hypersensitivity, etc.

Design outcomes

Primary

MeasureTime frame
ED90 of prophylactic single-dose phenylephrine;

Secondary

MeasureTime frame
Maternal adverse reactions: nausea, vomiting, chest tightness;Neonatal height and weight;Neonatal Apgar score (1 minute and 5 minutes);Neonatal umbilical cord blood gas analysis (acidosis, etc.);Comparison with previous left lateral positioning study results;

Countries

China

Contacts

Public ContactZhang Yueqi

Shanghai First Maternal and Infant Hospital

zyq0356232@126.com+86 139 1738 2427

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026