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Norepinephrine Consumption After Prophylactic Ondansetron

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928601
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Feride Karacaer, 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.

Condition or disease Intervention/treatment Phase
Maternal Hypotension Drug: Ondansetron Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia?
Study Start Date : November 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ondansetron Drug: Ondansetron
After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.

Active Comparator: Saline Drug: Saline
After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928601


Locations
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Turkey
Çukurova University
Adana, Turkey, 01330
Sponsors and Collaborators
Cukurova University
Investigators
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Study Director: Hakkı Ünlügenç, Professor Çukurova University
Publications of Results:
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Responsible Party: Feride Karacaer, Specialist doctor, Cukurova University
ClinicalTrials.gov Identifier: NCT02928601    
Other Study ID Numbers: NAOS1
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents