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Determination of the ED90 of Continuous Norepinephrine Infusion for Preventing Post-Spinal Hypotension in Women with Gestational Diabetes Mellitus: A Sequential Up-and-Down Study Using a Biased Coin Design

Determination of the ED90 of Continuous Norepinephrine Infusion for Preventing Post-Spinal Hypotension in Women with Gestational Diabetes Mellitus: A Sequential Up-and-Down Study Using a Biased Coin Design

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119947
Enrollment
Unknown
Registered
2026-03-05
Start date
2026-03-05
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

Women with gestational diabetes mellitus, aged 18-40 with a singleton pregnancy.

Interventions

NE group:using norepinephrine infusion to prevent hypotension

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: 1.Pregnant women with gestational diabetes mellitus (aged 18–40 years, singleton pregnancy) scheduled for elective cesarean delivery.

Exclusion criteria

Exclusion criteria: 1.Contraindications to neuraxial anesthesia; 2.Active labor; 3.Placenta previa or other placental abnormalities; 4.History of or pregnancy-induced hypertension, known cardiovascular or cerebrovascular disease; 5.Body weight 100 kg, height 180 cm; 6.Inability or refusal to provide informed consent; 7.Allergy to norepinephrine; 8.Other conditions deemed unsuitable for participation by the investigators (e.g., psychiatric disorders, inability to clearly communicate adverse drug reactions, etc.);

Design outcomes

Primary

MeasureTime frame
hypotension;Success rate of maintaining mean arterial pressure (MAP) >= 80% of baseline after subarachnoid anesthesia with a specified dose of norepinephrine infusion;

Secondary

MeasureTime frame
The incidence of bradycardia, tachycardia, hypertension, and nausea and vomiting;

Countries

China

Contacts

Public ContactLihong Sun

Women’s Hospital, Zhejiang University School of Medicine

sunlh1201@163.cm+86 571 8706 1501

Outcome results

None listed

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