Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients

• Status: Completed
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: All

Summary

Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting.

The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Treatments: Antiemetics; Olanzapine

Criteria

Inclusion criteria:

• Patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia

• Patients aged between 18 and 60 years

• Patients considered to be at high risk for PONV according to the Apfel scale (Apfel 3 or 4)

• Patients with a history of chemotherapy-induced nausea and vomiting.

Exclusion criteria:

• Pregnancy or Lactation

• Current use of typical anti-psychotic medications or atypical

• History of allergy to olanzapine

• Myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning

• History of severe ventricular arrhythmia (eg, VT or VF)

• Heart Failure Class II or greater second NYHA

• Postural hypotension or vasovagal syncope in the 6 months prior to the day of surgery planning

• Narrow angle glaucoma

• Parkinson's disease

• Dementia

• Inability to swallow medicines

• QT interval history greater than 450ms or torsades de pointes

• Patient does not want to participate in the study

• Videolaparoscopy surgery

• Contraindication for neuraxial block