Back to resultsReduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section
Primary Purpose
Hypotension
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ondansetron
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension
Eligibility 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.
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ondansetron
control
Arm Description
Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia
Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia
Outcomes
Primary Outcome Measures
Hypotension
Systolic BP <90 mmHg or Diastolic BP <60 mmHg
Secondary Outcome Measures
Bradycardia
HR <50 beats/min
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02913768
Brief Title
Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section
Official Title
Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Type
Drug
Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
Hypotension
Description
Systolic BP <90 mmHg or Diastolic BP <60 mmHg
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Bradycardia
Description
HR <50 beats/min
Time Frame
intraoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
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Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section
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