Ephedrine Versus Ondansetron During Cesarean Delivery

Spinal Induced Hypotension Clinical Trial

Official title:

Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127876
• Other study ID #: R 04 2022
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2022
• Est. completion date: March 6, 2022

Study information

• Verified date: September 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 6, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Spinal Induced Hypotension

Intervention

Drug:
• Ondansetron 4 MG
Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia
• Ondansetron 8mg
Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia
• EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution
Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia

Other:
• 10 mL normal saline
10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Maternal hypotension	Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min.	45 minutes
Secondary	Apgar score	1and 5 min after fetal delivery	5 min after fetal delivery