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The study of the optimal dose and effects on maternal and fetal of ondansetron in the prevention of hypotension during spinal anesthesia

The study of the optimal dose and effects on maternal and fetal of ondansetron in the prevention of hypotension during spinal anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003280
Enrollment
Unknown
Registered
2013-06-11
Start date
2013-07-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

hypotension during cesarean delivery

Interventions

Group S:Five min prior to spinal anesthesia, patients were intravenously injected with 5 ml saline
Group O2:Five min prior to spinal anesthesia, patients were intravenously injected with2mg ondansetron (diluted in 5 ml physiological saline)
Group O4:Five min prior to spinal anesthesia, patients were intravenously injected with4mg ondansetron (diluted in 5 ml physiological saline)
Group O6:Five min prior to spinal anesthesia, patients were intravenously injected with6mg ondansetron (diluted in 5 ml physiological saline)
Group O8:Five min prior to spinal anesthesia, patients were intravenously injected with8mg ondansetron (diluted in 5 ml physiological saline)

Sponsors

Wuxi Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: The patients were aged 18–35 years, all were at 37–42 weeks gestation, and all were classified as ASA grade I–II. All women had normal prenatal examinations, normal liver and renal function prior to caesarean delivery, and had no medical history of heart or lung diseases. In addition, fetal screening revealed no abnormalities.

Exclusion criteria

Exclusion criteria: Patients who met the following criteria were excluded from the study: 1. women with hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg); 2. women with cardiovascular and/or cerebrovascular diseases; 3. women with abnormal fetus development; 4. women with contraindications for intraspinal anesthesia or endocrine disorders such as diabetes mellitus; 5. women who were recently administered 5-hydroxytryptamine (5-HT) reuptake inhibitors or drugs for the treatment of migraines.

Design outcomes

Primary

MeasureTime frame
Blood pressure;Heart Rate;SpO2;Occurrence of hypotension;Occurrence of bradycardia;Occurrence of nausea;Occurrence of vomiting;Umbilical blood gas analysis;

Secondary

MeasureTime frame
Block height during spinal anesthesis;

Countries

China

Contacts

Public ContactMeng Wang
wxfy2071@163.com+86 13961700457

Outcome results

None listed

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