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Norepinephrine Consumption After Prophylactic Ondansetron

Primary Purpose

Maternal Hypotension

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Ondansetron

Saline

About this trial

This is an interventional prevention trial for Maternal Hypotension

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Çukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ondansetron

Saline

Arm Description

Outcomes

Primary Outcome Measures

Norepinephrine consumption

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

Bradicardia

Heart rate lower than 60 beat /min will be treated with iv 0.5 mg of atropine and recorded.

Full Information

NCT ID

NCT02928601

First Posted

October 6, 2016

Last Updated

August 21, 2017

Sponsor

Cukurova University

1. Study Identification

Unique Protocol Identification Number

NCT02928601

Brief Title

Norepinephrine Consumption After Prophylactic Ondansetron

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cukurova University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Maternal Hypotension

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ondansetron

Arm Type

Experimental

Arm Title

Saline

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Norepinephrine consumption

Description

Time Frame

During the cesarean operation

Secondary Outcome Measure Information:

Title

Bradicardia

Description

Heart rate lower than 60 beat /min will be treated with iv 0.5 mg of atropine and recorded.

Time Frame

During the cesarean operation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hakkı Ünlügenç, Professor

Organizational Affiliation

Çukurova University

Official's Role

Study Director

Facility Information:

Facility Name

Çukurova University

City

Adana

ZIP/Postal Code

01330

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

26421701

Citation

Gao L, Zheng G, Han J, Wang Y, Zheng J. Effects of prophylactic ondansetron on spinal anesthesia-induced hypotension: a meta-analysis. Int J Obstet Anesth. 2015 Nov;24(4):335-43. doi: 10.1016/j.ijoa.2015.08.012. Epub 2015 Aug 22.

Results Reference

result

PubMed Identifier

24515619

Citation

Wang Q, Zhuo L, Shen MK, Yu YY, Yu JJ, Wang M. Ondansetron preloading with crystalloid infusion reduces maternal hypotension during cesarean delivery. Am J Perinatol. 2014 Nov;31(10):913-22. doi: 10.1055/s-0033-1364189. Epub 2014 Feb 10.

Results Reference

result

Learn more about this trial

Norepinephrine Consumption After Prophylactic Ondansetron

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