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Could antivomiting agent ondansetron prevent low blood pressure during spinal anesthesia for caesarean section?

Efficacy of ondansetron in preventing hypotension during spinal anaesthesia for caesarean section

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001235594
Enrollment
90
Registered
2024-10-09
Start date
2024-11-11
Completion date
2024-12-30
Last updated
2024-10-14

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

Conditions

None listed

Brief summary

Hypotension provoked by spinal anaesthesia for caesarean section might be the cause of placental hypoperfusion and maternal discomfort. Ondansetron is antiemetic drug with potential favourable haemodynamic characteristics. Namely, it could prevent or attenuate maternal hypotensive episodes, providing maternal and foetal well-being. The study hypothesis is that intravenously given ondansetron will provide fewer episodes of hypotension and less overall vasopressor administration in the period from spinal anaesthesia commencement to delivery. The secondary goal is to assess the impact of ondansetron on the incidence of pruritus and shivering during operation and postoperatively.

Interventions

Spinal anaesthesia will be performed for elective caesarean section. The procedure will be performed in sitting position. Atraumatic spinal Whitacre needle, 27-gauge, 9 mm of length will be employed. The level of puncture by spinal needle will be between third and fourth or fourth and fifth lumbar vertebra. Upon confirmation of cerebrospinal fluid flow, the mixture of hyperbaric 0,5% bupivacaine, 25 mcg of fentanyl and 150 mcg of morphine will be administered intrathecally. Depending on pateint

Spinal anaesthesia will be performed for elective caesarean section. The procedure will be performed in sitting position. Atraumatic spinal Whitacre needle, 27-gauge, 9 mm of length will be employed. The level of puncture by spinal needle will be between third and fourth or fourth and fifth lumbar vertebra. Upon confirmation of cerebrospinal fluid flow, the mixture of hyperbaric 0,5% bupivacaine, 25 mcg of fentanyl and 150 mcg of morphine will be administered intrathecally. Depending on pateint's height, eight (in case that height is less than 165 cm) or ten miligrams of 0.5% hyperbaric bupivacaine will be given. Participants will be randomly assigned in one of three groups, namely control group and in two interventional groups. Participant in arm 2 will receive 4 mg (2 ml) of ondansetron intravenously diluted with 8 ml of saline in 10 ml syringe, while study participants in arm 3 will be given 8 mg (4ml) of ondansetron intravenously, diluted with 6 ml of saline in 10 ml syringe. Both interventional groups (arm 2 and arm3) will receive ondansetron 5 minutes before commencement of spinal anaesthesia procedure. The study drug will be previously prepared by anaesthesia resident, while attending anaesthesiologist will be unaware of syringe content. All participants in all three arms will receive 10 mg of metoclopramide intravenously after completion of intrathecal drug administration. All drugs administered in operating theatre during anesthesia will be recorded by anaesthesia resident.

Sponsors

Iva Pažur- University Hospital Centre Sestre milosrdnice
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Healty parturients scheduled for caesarean section in spinal anaesthesia

Exclusion criteria

Preeclampsia, eclampsia, contraindications for neuroaxial anesthesia (coagulopathies, infection at puncture site, aortic valve stenosis, central nervous system disorders).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026