Status:
UNKNOWN
ONDANSETRON AND EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAREAN DELIVERY
Lead Sponsor:
Laval University
Collaborating Sponsors:
CHU de Quebec-Universite Laval
Conditions:
Hypotension
Anesthesia; Adverse Effect, Spinal and Epidural
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Spinal anesthesia is the preferred technique for elective cesarean section as per ASA guidelines. Hypotension is the main complication of this technique and is secondary to both sympatholysis and its ...
Detailed Description
Vital signs are measured in the preparation area before entrance in the operation theater. The following measures are taken in the supine position every three minutes for three measures: blood pressur...
Eligibility Criteria
Inclusion
- parturients with a singleton pregnancy at term (37 week's gestation and more)
- elective cesarean delivery under spinal anesthesia
- American Society of Anesthesiologists physical status \< III
Exclusion
- patient refusal
- allergy or hypersensitivity to Norepinephrine or Ondansetron
- Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
- Long QT syndrome or another cause of prolonged QT
- significant preexisting maternal disease (cardiovascular or cerebrovascular disease or coagulopathy, diabetes mellitus)
- pre-existing or pregnancy-induced hypertension
- pathological pregnancy (ruptured membranes, pre-eclampsia, placenta praevia, gestational diabetes)
- body mass index \< 18 or \> 40
- height \< 150 or \> 180
- fetal abnormalities
- contraindication to spinal anesthesia
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04703088
Start Date
June 1 2021
End Date
August 1 2021
Last Update
January 12 2021
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