Norepinephrine Consumption After Prophylactic Ondansetron

Phase 4

Completed

• Conditions: Maternal Hypotension
• Interventions: Drug: Saline; Drug: Ondansetron

• Registration Number: NCT02928601
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Study Start: 2016-11
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Ondansetron	Ondansetron	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Çukurova University; 🇹🇷 Adana, Turkey