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

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-4gnm8n
• Date of registration: 10/11/2015
• Prospective Registration: No
• Primary sponsor: Hospital São Rafael
• Public title: Clinical study comparing palonosetron with ondansetron for prevention of nausea and vomiting after uterus surgery under spinal anesthesia with morphine
• Scientific title: Randomized clinical trial comparing palonosetron with ondansetron for prophylaxis of nausea and vomiting after abdominal hysterectomy under spinal anesthesia with morphine
• Date of first enrolment: 22/01/2015
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-4gnm8n
• Study type: Intervention
• Study design: Phase 4, parallel two-arm, randomized double-blinded clinical trial.
• Phase: 4

Countries of recruitment

Brazil

Contacts

• Name: Guilherme Oliveira Campos
• Affiliation: Hospital São Rafael

• Name: Guilherme Oliveira Campos
• Affiliation: Hospital São Rafael

Key inclusion & exclusion 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: 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.

Age minimum: 18Y
Age maximum: 65Y
Gender: F

Health Condition(s) or Problem(s) studied

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Leiomyoma of uterus, abdominal hysterectomy, Nausea and Vomiting.

Intervention(s)

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D27.505.696.663.050.030

Drug

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 4mg of ondansetron, while patients in Group 2 will receive intravenous dexamethasone 8 mg and 0.075 mg of palonosetron. The antiemetic medications will be prepared by trained nurses who will not be involved in the analysis of the variables studied.

Primary Outcome(s)

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 Outcome(s)

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).

Source(s) of Monetary Support

Hospital São Rafael

Secondary Sponsor(s)

Hospital São Rafael