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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02862873

Acronym

ZORA

Enrollment

Registered

2016-08-11

Start date

2015-03-31

Completion date

Unknown

Last updated

2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Spinal anaesthesia

Brief 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.

Interventions

PROCEDURESpinal anaesthesia

DRUGOndansetron

OTHERsaline solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026