Norepinephrine Consumption After Prophylactic Ondansetron

Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02928601

Enrollment

108

Registered

2016-10-10

Start date

2016-11-30

Completion date

2017-08-31

Last updated

2017-08-22

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

Conditions

Maternal Hypotension

Brief summary

This study evaluates the effect of prophylactic ondansetron on the incidence of spinal hypotension and vasopressor consumption in caesarean section patients using norepinephrine treatment. Half of participants receive ondansetron before spinal anesthesia while the other half receive saline.

Detailed description

Spinal hypotension in cesarean section patients can occur vigorously and may lead to cardiovascular collapse. If doesn't treated precipitously, It can cause maternal hypotension, nausea and vomiting and fetal acidosis. Recently norepinephrine has been proposed for the prevention and treatment of spinal hypotension with less tendency to decrease HR and CO. It has been reported that ondansetron can be used for prophylaxis and treatment of nausea and vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean section with spinal anesthesia. The aim of the present study is to assess the effect of prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension, and side effects such as maternal nausea, vomiting and bradycardia.

Interventions

DRUGOndansetron

After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.

DRUGSaline

After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* ASA physical status I-II patients * Between the ages of 18 and 40 years * Scheduled for elective caesarean section with spinal anesthesia

Exclusion criteria

* History of hypertension * History of severe hepato-renal disease, * sensitivity or contraindication to ondansetron, * Drug or alcohol abuse * Contraindication to regional anesthesia.

Design outcomes

Primary

Measure	Time frame	Description
Norepinephrine consumption	During the cesarean operation	Whenever systolic arteriel pressure falls below 100 mmHg or below 20% of the preoperative baseline value in both groups norepinephrine (5 µg) will be administered intravenously and total consumption will be recorded.

Secondary

Measure	Time frame	Description
Bradicardia	During the cesarean operation	Heart rate lower than 60 beat /min will be treated with iv 0.5 mg of atropine and recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

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