Comparison of the effect of intravenous ondansetron administration on vasopressor requirements and the corrected QT for preventing spinal hypotension during cesarean delivery under spinal anesthesia: A Prospective, Randomized, double-blinded study
- Conditions
- Pregnancy, childbirth and the puerperium
- Registration Number
- KCT0009435
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 110
1) Singleton, Gestational age 37 weeks or more
2) Scheduled for spinal anesthesia
3) from 20 years to 45 years
4) No contraindications of spinal anesthesia
5) Body mass index 35 kg/m2 or less
6) American society of anesthesiologists physical status 2
1) Past history of side effects related to the use of ondansetron, history of inadequate response to the antiemetic effect of ondansetron
2) Failure of spinal anesthesia (conversion to general anesthesia, unexpected analgesia or sedatives administration due to inadequate spinal anesthesia)
3) Emergency cesarean section (category 1) such as placental abruption, umbilical cord prolapse
4) Cases where blood transfusion is expected (etc. placenta accreta spectrum)
5) Accompanying pregnancy related complications such as hypertension, pre-eclampsia, eclampsia , etc
6) Magnesium treatment during the pre/postoperative period
7) Electrolyte imbalance including hypokalemia, hypomagnesemia and others, Drug administration causing electrolyte imbalance
8) Congestive heart failure, possibility or presence of Long QT syndrome, and brady-arrhythmia
9) Administration of Selective-serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor
10) Drug administration related to QT prolongation: Cardiotoxic drugs (e.g.anthracycline), antibiotics (e.g.erythromycin), anti-fungal agents (e.g.ketoconazol), anti-arrhythmic agents (e.g.amiodarone), beta-blocker, etc
11) If there is or is expected to be a neurological deficit
12) Expected birth weight less than 1500 (Very low birth weight)
13) Patient who have already administered a Selective 5-HT3 receptor antagonist, or patients having an allergy or hypersensitivity to selective 5-HT3 receptor antagonist
14) Regarded as inappropriate to participate this study by Medical staff
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of vasopressor before baby delivery
- Secondary Outcome Measures
Name Time Method The change of corrected QT after administration of a drug