Clinical trial NCT05127876: Ephedrine Versus Ondansetron During Cesarean Delivery
Official title: Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Induced Hypotension
Keywords: cesarean section
Bezold-Jarisch reflex
ondansetron
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: According to patients' randomized groups, study medication was given over 1 min, 5 min before spinal anesthesia

Patients were randomly assigned into 1 of 4 groups, using computer generated sequence and opaque envelopes, according to the prophylactic intravenous drug dose used:

* Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute;
* Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute;
* Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute;
* Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Maternal hypotension
timeFrame: 45 minutes
Secondary outcomes:
measure: Apgar score
timeFrame: 5 min after fetal delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References: