Prevention of nausea and vomiting comparing ondansetron and dexamethasone versus placebo in cesarean section under regional anesthesia

Prophylaxis of postoperative nausea and vomiting in cesarean section under spinal anesthesia with intrathecal morphine: controlled clinical trial comparing ondansetron vs placebo vs dexamethasone

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57227250

Enrollment

300

Registered

2016-07-17

Start date

2015-09-17

Completion date

Unknown

Last updated

2019-09-02

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

Conditions

1. Postoperative nausea and vomiting 2. Pruritus Signs and Symptoms

Interventions

300 patients are randomized to one of three groups in a 1:1:1 ratio. Ondansetron group: Participant receive 4 mg of ondansetron in 5 mL normal saline Dexamethasone gro

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pregnant patients scheduled for elective caesarean 2. Age between 18 - 40 years old 3. Spinal (Subarachnoid) anesthesia with intrathecal morphine 4. ASA Physical status 1-2

Exclusion criteria

Exclusion criteria: 1. Preeclampsia 2. Eclampsia 3. Kidney and/or liver failure 4. Known allergy to ondansetron or dexamethasone 5. Heart disease 6. Vertigo 7. Hyperemesis gravidarum 8. Nausea and vomiting or itching 9. Previous cesarean section 10. 5 HT3 antagonists or corticoids allergy 11. Gestational diabetes 12. Immunosuppression 13. Congenital long QT syndrome 14. Neurological or psychiatric illness that would prevent obtaining consent for the study Emergency Caesarean .

Design outcomes

Primary

Measure	Time frame
1. Incidence of nausea and vomiting is measured using a numerical rating scale (NRS) at 2, 6 and 24 hours after intrathecal morphine 2. Relative risk of nausea and vomiting by dividing the percentage cases of nausea and vomiting in the control group by the percentage cases in each of the intervention groups 3. Number needed to treat for nausea and vomiting is measured by the inverse of the Absolute Risk reduction (ARR) (% of cases of nausea on placebo group - % of cases of nausea on ondansetron or dexamethasone group) intraoperatively, at 2, 6 and 24 hours after intrathecal morphine	—

Measure

Time frame

1. Incidence of nausea and vomiting is measured using a numerical rating scale (NRS) at 2, 6 and 24 hours after intrathecal morphine 2. Relative risk of nausea and vomiting by dividing the percentage cases of nausea and vomiting in the control group by the percentage cases in each of the intervention groups 3. Number needed to treat for nausea and vomiting is measured by the inverse of the Absolute Risk reduction (ARR) (% of cases of nausea on placebo group - % of cases of nausea on ondansetron or dexamethasone group) intraoperatively, at 2, 6 and 24 hours after intrathecal morphine

—

Secondary

Measure	Time frame
1. Incidence of pruritus is measured using a numerical rating scale (NRS) intraoperatively, at 2, 6 and 24 hours after intrathecal morphine 2. Relative risk of pruritus by dividing the percentage cases of pruritus in the control group by the percentage cases in each of the intervention groups	—

Countries

Colombia

Contacts

Public ContactRodolfo Parra Güiza

Outcome results

None listed

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