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Clinical trial

Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial

ID
Name
IRB: 17300536
Description
Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug.
Trial arms
Trial start
2021-03-15
Estimated PCD
2023-02-01
Trial end
2023-02-01
Status
Completed
Phase
Early phase I
Treatment
Placebo
oral Placebo tablets one-hour preoperatively
Arms:
Group 1
5 mg Olanzapine Tablets
oral 5 mg Olanzapine tablets one-hour preoperatively
Arms:
Group 2
Other names:
zyprexa
10 mg Olanzapine Tablets
oral 10 mg Olanzapine tablets one-hour preoperatively
Arms:
Group 3
Other names:
zyprexa
Size
132
Primary endpoint
nausea and/or vomiting score
first 24 hours postoperative
Eligibility criteria
Inclusion Criteria: * ASA I and II patients * undergoing ambulatory laparoscopic gynecologic surgery with general anesthesia * patients have at least two of the four Apfel risk factors for PONV2 * Lack of history of psychiatric and psychotic illnesses. Exclusion Criteria: * ASA III and ≥ IV patients * Psychological diseases * History of chemotherapy * have a pre-existing vestibular disorder or history of dizziness or preexisting nausea or vomiting in the 24 h before surgery, or were being treated with regular antiemetic therapy including systemic corticosteroids.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 132, 'type': 'ACTUAL'}}
Updated at
2023-03-09

1 organization

1 product

1 drug

1 indication

Organization
Amani Hassan Abdel-Wahab
Drug
Varlilumab
Indication
postoperative nausea
Product
Olanzapine