Palonosetron versus ondansetron in preventing intrathecal morphine-induced postoperative nausea, vomiting, and pruritus in cesarean delivery: a double-blinded, randomized, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210611005

Enrollment

300

Registered

2021-06-11

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

postoperative nausea, vomiting, and pruritus after intrathecal morphine use in cesarean delivery postoperative nausea vomiting pruritus palonosetron ondansetron intrathecal opioid intrathecal morphine cesarean section cesarean delivery

Interventions

palonosetron 0.075 mg intravenously,ondansetron 4 mg intravenously,normal saline 5 ml intravenously

Experimental Drug,Experimental Drug,Placebo Comparator No treatment

palonosetron,ondansetron,placebo

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: ASAII parturient aged 18 years or above scheduled for elective cesarean delivery under spinal anesthesia

Exclusion criteria

Exclusion criteria: 1. Known allergy or contraindication to ondansetron, palonosetron, and other drugs in the study protocol 2. Having contraindication to or refusal of spinal anesthesia 3. Parturient with pregnancy-related complication such as fetal distress, severe pre-eclampsia 4. Parturient with preoperative symptoms of nausea and vomiting 5. Having coexisting skin disorder or pruritic skin disease 6. A patient who had received antiemetic, emetogenic, or steroid medication 7. The participant who needs an anesthetic technique conversion to general anesthesia

Design outcomes

Primary

Measure	Time frame
postoperative nausea, vomiting, pruritus PACU at 0, 30, 60, 90, 120 minutes after arrival and at the hospital ward at 6, 12, 24, 36, and 48 hours from the time of PACU arrival nausea and vomiting score (0 for no nausea or vomiting, 1 for mild nausea, 2 for severe nausea requiring rescue treatment, 3 for vomiting)	—

Secondary

Measure	Time frame
postoperative pruritus PACU at 0, 30, 60, 90, 120 minutes after arrival and at the hospital ward at 6, 12, 24, 36, and 48 hours from the time of PACU arrival pruritus score (0 for no pruritus, 1 for mild pruritus, 2 for moderate pruritus requiring rescue treatment, 3 for severe pruritus)	—

Countries

Thailand

Contacts

Public ContactTarvit Worravitudomsuk

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn university

prmdcu@gmail.com022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026