Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Amani Hassan Abdel-Wahab

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postoperative Nausea

Treatments: Drug: Placebo; Drug: 5 mg Olanzapine Tablets; Drug: 10 mg Olanzapine Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04718727

IRB: 17300536

Details and patient eligibility

About

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.

Full description

Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Enrollment: 132 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 3 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

patients will receive oral placebo tablets one hour preoperatively

Treatment:

Drug: Placebo

Group 2

Active Comparator group

Description:

patients will receive oral 5 mg Olanzapine tablets one hour preoperatively

Treatment:

Drug: 5 mg Olanzapine Tablets

Group 3

Active Comparator group

Description:

patients will receive oral 10 mg Olanzapine tablets one hour preoperatively

Treatment:

Drug: 10 mg Olanzapine Tablets