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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0009435
Enrollment
110
Registered
2024-05-16
Start date
2024-07-04
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. Ondansetron (Onseran, 8mg, 4ml, Yuhan, Group O) or normal saline (4ml, Group Ca) infusion via intravenous line 2. Ondansetron or normal saline 5-10 minutes before spinal anesthetic drug i

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The amount of vasopressor before baby delivery

Secondary

MeasureTime frame
The change of corrected QT after administration of a drug

Countries

Korea, Republic of

Contacts

Public ContactHeesun Park

Asan Medical Center

lenadiar@naver.com+82-2-3010-0649

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026