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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913768
• Other study ID #: Ondansetron for CS
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Ondansetron

• Normal saline

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	Systolic BP <90 mmHg or Diastolic BP <60 mmHg	intraoperative
Secondary	Bradycardia	HR <50 beats/min	intraoperative