Interest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section

Hypotension Clinical Trial

— ZORA  

Official title:

Iinterest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section: Double-blind Randomized Controlled Single-centre Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02862873
• Other study ID #: GIRARD WOLFF 2014
• Status: Terminated
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 10, 2016
• Start date: March 2015

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP).

The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates.

It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant.

One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses.

The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section.

The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persons who have provided written informed consent

• Persons with national health insurance cover

• Patients aged over 18 years, ASA I or II

• About to undergo scheduled or non-scheduled caesarean section under spinal anaesthesia

Exclusion Criteria:

• Adults under guardianship

• Contra indication for spinal anaesthesia (SA) (refusal, haemodynamic instability, innate or acquired coagulation disorder)

• History of hypersensitivity to Zophren or local anaesthetics

• Heart and/or kidney failure

• Treatment with angiotensin converting enzyme (ACE) inhibitor, Beta Blockers, or angiotensin II receptor antagonist (ARA II), Zophren, atropine, Selective Serotonin Reuptake Inhibitors, Triptans

• Caesarean in a context of extreme emergency, with a time to foetal extraction incompatible with SA and the injection of Zophren, (up to 30 minutes) and requiring consent in an emergency.

• Pregnancy-related arterial hypertension (AHT)

• Pre-eclampsia

• Gestational diabetes

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension

Intervention

Procedure:
• Spinal anaesthesia

Drug:
• Ondansetron

Other:
• saline solution

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of Systolic blood pressure below 90 mmHg		every 2 minutes from the intrathecal injection for 20 minutes, and then every 5 minutes until the end of the surgery.	Yes