Norepinephrine Consumption After Prophylactic Ondansetron

Maternal Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928601
• Other study ID #: NAOS1
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2016
• Last updated: August 21, 2017
• Start date: November 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Maternal Hypotension

Intervention

Drug:
• Ondansetron
After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.
• Saline
After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.

Locations

Country	Name	City	State
Turkey	Çukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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