benign gynecological disease
Conditions
Interventions
Oral olanzapine 5 mg 2h prior to anesthesia induction
Placebo 2h prior to anesthesia indcution
Sponsors
Keio University Hospital
Showa University Hospital Jikei University School of Medicine Hospital Nagoya City University Hospital Kyoto Prefectural Medical University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients undergoing laparoscopic gynecological surgery for benign gynecological disease, expected to last at least 1h who are equal to or older than 20 years old and have one or two of the following risk factors for PONV: (1) non-smoking status, (2) a prior history of motion sickness or PONV.
Exclusion criteria
Exclusion criteria: Patients with diabetes, those who took antiemetic agents within 1 month prior to the surgery and those who take olanzepine, pregnant, parturient and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of PONV within 24h after laparoscopic gynecological surgery. Nausea was defined as a subjective feeling of a desire to vomit without the presence of expulsive muscular movements. Vomiting was defined as the involuntary, forceful expulsion of the contents of stomach. A patient was considered to have PONV if she experienced any episodes of nausea or emesis (vomiting or retching), or if she used rescue antiemetics after tracheal extubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first PONV Incidence of PONV, emesis, worst VAS score for nausea, incidence of significant nausea (VAS score for nausea equal to or more than 40), use of rescue metoclopramide in the 0-0.5, 0.5-2, 2-6, and 6-24 h after surgery The VAS score for patient satisfaction regarding nausea | — |
Countries
Japan
Contacts
Public ContactHiroyuki Seki
Keio University School of Medicine Department of Anesthesiology
Outcome results
None listed