Ondansetron Prior Spinal Anaesthesia

Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06431568

Acronym

Ondansetron

Enrollment

400

Registered

2024-05-28

Start date

2023-10-01

Completion date

2024-05-01

Last updated

2024-05-28

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

Conditions

Cesarean Section

Keywords

Spinal anesthesia, Cesarean section, Ondansetron

Brief summary

Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

Detailed description

Hypothesis: Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia. Aim: Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration. Objectives: * Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not * Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Pregnant patients undergoing elective caesarean section

Exclusion criteria

* Preeclampsia * Eclampsia * Hypertension * Diabetes

Design outcomes

Primary

Measure	Time frame	Description
Blood Pressure	one hour	incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron

Secondary

Measure	Time frame	Description
Heart rate	One hour	Incidence of bradycardia after ondansetron
Vasopressor	One hour	Incidence of use of ephedrine or phenylpherine

Countries

Egypt

Outcome results