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Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913768
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mostafa Samy Abbas, Assiut University

Brief Summary:
Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is associated with hypotension and bradycardia, which may be deleterious to both parturient and baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following subarachnoid block in parturients undergoing elective caesarean section.

Condition or disease Intervention/treatment Phase
Hypotension Drug: Ondansetron Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study
Study Start Date : October 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : January 2018

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Arm Intervention/treatment
Active Comparator: Ondansetron
Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia
Drug: Ondansetron
Placebo Comparator: control
Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia
Drug: Normal saline



Primary Outcome Measures :
  1. Hypotension [ Time Frame: intraoperative ]
    Systolic BP <90 mmHg or Diastolic BP <60 mmHg


Secondary Outcome Measures :
  1. Bradycardia [ Time Frame: intraoperative ]
    HR <50 beats/min



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing an elective lower segment caesarean section.

Exclusion Criteria:

  • Patients with contraindications to subarachnoid block (patient refusal, unstable haemodynamics, coagulation abnormality),
  • History of hypersensitivity to ondansetron or local anaesthetic agents,
  • Hypertensive disorders of pregnancy,
  • Cardiovascular insufficiency,
  • Receiving selective serotonin reuptake inhibitors or migraine medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913768


Locations
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Egypt
Assiut University hospital
Assiut, Asyut Governorate, Egypt, 11111
Sponsors and Collaborators
Assiut University
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Responsible Party: Mostafa Samy Abbas, lecturer of anesthesia and ICU, Assiut University,Assiut, Egypt, Assiut University
ClinicalTrials.gov Identifier: NCT02913768    
Other Study ID Numbers: Ondansetron for CS
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents