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

Phase 4

Completed

• 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

• Registration Number: TCTR20210611005
• Lead Sponsor: King Chulalongkorn Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-11
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)