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

Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02913768
Enrollment
160
Registered
2016-09-26
Start date
2016-10-31
Completion date
2018-01-31
Last updated
2019-08-28

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

Conditions

Hypotension

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.

Interventions

DRUGOndansetron
DRUGNormal saline

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HypotensionintraoperativeSystolic BP \<90 mmHg or Diastolic BP \<60 mmHg

Secondary

MeasureTime frameDescription
BradycardiaintraoperativeHR \<50 beats/min

Countries

Egypt

Outcome results

None listed

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