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NCT Number: NCT02928601

Norepinephrine Consumption After Prophylactic Ondansetron

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.

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Key information

Conditions

Maternal Hypotension

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Çukurova University

Adana, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

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

Saline

Drug

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

Primary outcomes

  1. Norepinephrine consumption

    Time frame: 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 outcomes

  1. Bradicardia

    Time frame: During the cesarean operation

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

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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