NCT02862873

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

August 4, 2016

Last Update Submit

August 10, 2016

Conditions

Hypotension

Keywords

Spinal anaesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Ondansetron

EXPERIMENTAL
Procedure: Spinal anaesthesiaDrug: Ondansetron

Saline solution

PLACEBO COMPARATOR
Procedure: Spinal anaesthesiaOther: saline solution

Interventions

Spinal anaesthesiaPROCEDURE
OndansetronSaline solution
OndansetronDRUG
Ondansetron
saline solutionOTHER
Saline solution

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Hypotension

Interventions

Anesthesia, SpinalOndansetronSaline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 11, 2016

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Last Updated

August 11, 2016

Record last verified: 2016-06

Locations

FR(1)