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

Primary Purpose

Hypotension

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spinal anaesthesia
Ondansetron
saline solution
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Spinal anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • CHU Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ondansetron

Saline solution

Arm Description

Outcomes

Primary Outcome Measures

number of Systolic blood pressure below 90 mmHg

Secondary Outcome Measures

Full Information

First Posted
August 4, 2016
Last Updated
August 10, 2016
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02862873
Brief Title
Interest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Spinal anaesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Experimental
Arm Title
Saline solution
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Type
Other
Intervention Name(s)
saline solution
Primary Outcome Measure Information:
Title
number of Systolic blood pressure below 90 mmHg
Time Frame
every 2 minutes from the intrathecal injection for 20 minutes, and then every 5 minutes until the end of the surgery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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