Ondansetron for Postspinal Anesthesia Hypotension

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Adverse Effect

Treatments: Drug: normal saline; Drug: Ondansetron 4 mg; Drug: Ondansetron 8 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05475873

Yi Chen-2022-1

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Full description

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Ondansetron have been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-40 years
• Primipara or multipara
• Singleton pregnancy ≥ 37 weeks
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for elective cesarean section under spinal anesthesia

Exclusion criteria

• Body height < 150 cm
• Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
• Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
• Hemoglobin < 7g/dl
• Fetal distress, or known fetal developmental anomaly

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Control group

Sham Comparator group

Description:

A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.

Treatment:

Drug: normal saline

Ondansetron 4 mg

Experimental group

Description:

A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.

Treatment:

Drug: Ondansetron 4 mg

Ondansetron 8 mg

Experimental group

Description:

A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.

Treatment:

Drug: Ondansetron 8 mg