Norepinephrine Consumption After Prophylactic Ondansetron

Çukurova University

Status and phase: Completed; Phase 4

Conditions: Maternal Hypotension

Treatments: Drug: Saline; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02928601

NAOS1

Details and patient eligibility

About

This study evaluates the effect of prophylactic ondansetron on the incidence of spinal hypotension and vasopressor consumption in caesarean section patients using norepinephrine treatment. Half of participants receive ondansetron before spinal anesthesia while the other half receive saline.

Full description

Spinal hypotension in cesarean section patients can occur vigorously and may lead to cardiovascular collapse. If doesn't treated precipitously, It can cause maternal hypotension, nausea and vomiting and fetal acidosis. Recently norepinephrine has been proposed for the prevention and treatment of spinal hypotension with less tendency to decrease HR and CO. It has been reported that ondansetron can be used for prophylaxis and treatment of nausea and vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean section with spinal anesthesia. The aim of the present study is to assess the effect of prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension, and side effects such as maternal nausea, vomiting and bradycardia.

Enrollment: 108 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA physical status I-II patients
• Between the ages of 18 and 40 years
• Scheduled for elective caesarean section with spinal anesthesia

Exclusion criteria

• History of hypertension
• History of severe hepato-renal disease,
• sensitivity or contraindication to ondansetron,
• Drug or alcohol abuse
• Contraindication to regional anesthesia.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Ondansetron

Experimental group

Treatment:

Drug: Ondansetron

Saline

Active Comparator group

Treatment:

Drug: Saline