Ephedrine Versus Ondansetron During Cesarean Delivery

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Spinal Induced Hypotension

Treatments: Drug: Ondansetron 4 MG; Drug: Ondansetron 8mg; Other: 10 mL normal saline; Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05127876

R 04 2022

Details and patient eligibility

About

More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death.

The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.

Full description

Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery.

Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.

Enrollment: 168 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >18, <40 years;
• American Society of Anesthesiologists physical status I or II;
• term pregnancy
• singleton pregnancy;
• elective cesarean delivery under spinal anesthesia

Exclusion criteria

• Patients with a history of diabetes mellitus other than gestational diabetes,
• hypertension,
• body mass index >40 kg/m2,
• complicated pregnancy, allergy to study drugs,
• long QT syndrome,
• Contraindication to spinal anesthesia
• Patients who required general anesthesia were withdrawn from the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 4 patient groups, including a placebo group

Group E

Experimental group

Description:

Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.

Treatment:

Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution

Group OL

Experimental group

Description:

Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.

Treatment:

Drug: Ondansetron 4 MG

Group OH

Experimental group

Description:

Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered.

Treatment:

Drug: Ondansetron 8mg

Group P

Placebo Comparator group

Description:

Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo. Then under aseptic precautions, spinal anesthesia was administered.

Treatment:

Other: 10 mL normal saline