Effects of Ondansetron on Hemodynamics in Cesarean Section Under Spinal Anesthesia

• Status: Completed
• Trial end date: 2017-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

BACKGROUND:

Spinal anesthesia (SA) induced maternal hypotension is the most frequent and troublesome complication in cesarean section (CS), compromising both maternal and neonatal well-being. Many strategies have been used to prevent its occurrence but no single technique has been confirmed to be completely effective. the investigators hypothesized that ondansetron, a serotonin-receptor-antagonist, could have beneficial effects on maternal hemodynamics during CS under SA.

METHODS:

In this prospective double-blind placebo-controlled study, one hundred healthy parturients were randomized to receive either 8 mg of intravenous ondansetron (group O) or the same volume of saline (group S), 5 minutes prior to the induction of SA. All women received a coloading volume of 500 ml of saline. Maternal hemodynamics: blood pressure, heart rate and cardiac output (CO) were measured with a non-invasive device based on pulse wave transit time: the esCCO device Nihon Kohden hemodynamic monitor. Ephedrine was administered to treat hypotension (systolic blood pressure less than 80% of baseline).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Mahdia
• Treatments: Anesthetics; Ondansetron

Criteria

Inclusion Criteria:

Parturients eligible for the present study are women who:

• are scheduled for elective cesarean section under spinal anesthesia

• aged between 20 to 40 years

• are with an American Society of Anesthesiologist (ASA) physical status of I-II

• are with a normal liver and renal function and fetal screening, and with no medical history of heart disease.

• are with a single fetus.

Exclusion Criteria:

• Refusal to participate.

• Contraindication to spinal anesthesia

• Age <20 or >40 years.

• Obesity (body mass index (BMI) at term >35 kg/m2).

• History of hypersensitivity to study's drugs.

• History of long QT syndrome

• Hypertensive disorders of pregnancy.

• Women receiving selective serotonin reuptake inhibitors or migraine medications.

• Urgent cesarean section.

• Multiple pregnancies.

• Failure of spinal anesthesia.

• Conversion to general anesthesia.

• The occurrence of an anesthetic or surgical complication.