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Exploration of Rescue Doses Following Failed Prophylaxis with Continuous Norepinephrine Infusion for Post-Spinal Hypotension in Cesarean Delivery: A Sequentially Allocated Dose-Response Trial

Exploration of Rescue Doses Following Failed Prophylaxis with Continuous Norepinephrine Infusion for Post-Spinal Hypotension in Cesarean Delivery: A Sequentially Allocated Dose-Response Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102216
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Hypotension after spinal anesthesia

Interventions

Sequentially allocated:The starting rescue dose was 0.05 µg/kg, and the remedial dose was increased by 0.025 µg/kg each time after failure of prophylaxis, with an upper limit of 0.15 µg/kg
if the remedial dose was successful, the next remedial dose was a reduction of 0.025 µg/kg with a 1/9 probability, and the original dose with a lower limit of 0.05 µg/kg with an 8/9 probability.

Sponsors

Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients scheduled for elective cesarean section under spinal anesthesia (single fetus, term pregnancy, aged 18–45 years)

Exclusion criteria

Exclusion criteria: Hypertension, severe liver or kidney diseases, cardiovascular and cerebrovascular diseases, height 180 cm, body weight 100 kg, coagulation dysfunction, baseline systolic blood pressure <100 mmHg.

Design outcomes

Primary

MeasureTime frame
Success rates of different rescue doses;

Secondary

MeasureTime frame
Block level;Time from skin incision to fetal delivery;Time from anesthesia induction to fetal delivery;Heart rate;Pulse oxygen saturation;Pressure;Mean arterial pressure;Fetal Apgar score;Umbilical artery blood gas analysis;

Countries

China

Contacts

Public ContactWenyuan Lyu

Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University

lwyjerry@163.com+86 185 6181 1387

Outcome results

None listed

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