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Clinical study comparing palonosetron with ondansetron for prevention of nausea and vomiting after uterus surgery under spinal anesthesia with morphine

Randomized clinical trial comparing palonosetron with ondansetron for prophylaxis of nausea and vomiting after abdominal hysterectomy under spinal anesthesia with morphine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4gnm8n
Enrollment
Unknown
Registered
2015-11-10
Start date
2015-01-22
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Leiomyoma of uterus, abdominal hysterectomy, Nausea and Vomiting.

Interventions

Patients will be randomly divided into 2 groups (65 patients in each group) according to the antiemetic prophylaxis used intraoperatively. Group 1 will receive intravenously 8mg of dexamethasone and 4
Drug

Sponsors

Hospital São Rafael
Lead Sponsor
Hospital São Rafael
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: One hundred and thirty patients classified as American Society of Anesthesiologists (ASA) physical status 1 or 2; aged between 18 and 65 years.

Exclusion criteria

Exclusion criteria: Patients who received corticosteroids and antiemetic drugs in the 24 hours before the procedure; ASA physical status III or IV; allergy to medications involved in protocol; situations that contraindicate to perform spinal anesthesia.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative nausea and vomiting in both groups. Patients will be inquired about the presence or absence of these symptoms at the intervals of 0-2h, 2-24h and 24-48h. The intensity of nausea is evaluated by visual analog scale (0: no 10: maximum), amd vomiting will be determined as present or absent, as the frequency of happening.

Secondary

MeasureTime frame
Incidence of itching and pain. Patients will be inquired about the presence or absence of these symptoms at the intervals of 0-2h, 2-24h and 24-48h. The intensity of pain and itching will be assessed by visual analog scale (0: no 10: maximum).

Countries

Brazil

Contacts

Public ContactGuilherme Campos

Hospital São Rafael

guioliveiracampos@gmail.com+55 71 32816290

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 2, 2026