Prevention of low blood pressure with ondansetron for spinal anesthesia in patients undergoing cesarean section: placebo-controlled clinical trial

Hypotension prophylaxis with ondansetron for spinal anesthesia in patients undergoing cesarean section: placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-5y3w37m

Enrollment

Unknown

Registered

2021-05-28

Start date

2019-09-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Pregnant women, hypotension prophylaxis during cesarean section

Interventions

In the intervention group, 95 patients will be administered 4 mg of intravenous ondansetron (diluted in 0.9% NaCl saline to a volume of 10 ml), 5 minutes before spinal anesthesia for cesarean section,

D017294

D007022

Eligibility

Sex/Gender

Female

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 15 years, undergo spinal anesthesia for cesarean delivery and surgical risk ASA II or III (American Society of Anesthesiology Classification)

Exclusion criteria

Exclusion criteria: Long QT syndrome, pacemaker use, ondansetron allergy, patients using ondansetron in the last 24 hours and obstetric emergencies

Design outcomes

Primary

Measure	Time frame
To compare between the intervention group and the control group the incidence of hypotension after spinal anesthesia until the birth of the fetus, measured by multiparametric monitor (Alfamed VITA400). Measurements are taken every 3 minutes. Hypotension is defined as any decrease in diastolic or systolic blood pressure (measured in mmHg) from preoperative baseline values (mean of the patient's last two measurements during hospitalization).	—

Measure

Time frame

To compare between the intervention group and the control group the incidence of hypotension after spinal anesthesia until the birth of the fetus, measured by multiparametric monitor (Alfamed VITA400). Measurements are taken every 3 minutes. Hypotension is defined as any decrease in diastolic or systolic blood pressure (measured in mmHg) from preoperative baseline values (mean of the patient's last two measurements during hospitalization).

—

Secondary

Measure	Time frame
To compare the mean intraoperative blood pressure (in mmHg) and heart rate (in beats per minute), recorded every 3 min between groups. Compare the incidence of intraoperative nausea, vomiting and itching between the two groups. Compare vasopressor consumption (in milligrams) between the two groups.	—

Countries

Brazil

Contacts

Public ContactSérgio Menezes

Hospital das Clínicas

sergiovdsm@gmail.com+55-081-992161866

Outcome results

None listed

Source: REBEC (via WHO ICTRP)