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

NCT02913768 | Completed Phase 4

• 1 other identifier: Ondansetron for CS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• Hypotension

  Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg

  intraoperative

Secondary Outcomes (1)

• Bradycardia

  intraoperative

Study Arms (2)

Ondansetron

ACTIVE COMPARATOR

Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia

Drug: Ondansetron

control

PLACEBO COMPARATOR

Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia

Drug: Normal saline

Interventions

Ondansetron DRUG

Ondansetron

Normal saline DRUG

control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing an elective lower segment caesarean section.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Ondansetron; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and ICU, Assiut University,Assiut, Egypt

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

EG (1)