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NCT05676294
The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery
Conditions: Postoperative Nausea and Vomiting
Sex: Female
Ages: 18 Years – 50 Years
Phase: PHASE2
Enrollment: 455
Sponsor: Yale University
Location: United States
Summary
The primary objective of this phase 2 randomized controlled trial is to determine whether the pre-operative administration of olanzapine (5 mg PO) improves quality of recovery (assessed by the Quality of Recovery-40 (QoR-40) survey) on postoperative day 1 in patients having ambulatory surgery with general anesthesia.The secondary objectives of this study are to determine whether there are differences in quality of recovery on postoperative day 2, presence of post-discharge nausea, presence of severe post-discharge nausea, recovery room length of stay and opioid consumption in patients who receive the study drug versus placebo.
Eligibility Criteria
Inclusion Criteria:Provision of signed and dated informed consent formStated willingness to comply with all study procedures and availability for the duration of the studyFemale aged 18-50Scheduled to undergo ambulatory surgery under general anesthesiaAccess to smartphone device or computer with internet connection and has an email addressExclusion Criteria:Non-English speakingUnable to swallow pillsCurrent use of anti-psychotic medicationsHistory of allergy to olanzapinePregnancy/LactationCurrent use of antihypertensive medicationDiabetes MellitusClinically significant cardiovascular disease defined as follows:Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on anti-arrhythmic medication.New York Heart Association Class II or higher congestive heart failure.Postural hypotension or vasovagal syncope within 6 months of planned surgery.Hypotension on day of surgery, defined as a systolic blood pressure < 90mmHgSeizure disorderClinically active prolactinomaHepatic diseaseNarrow angle glaucomaParkinson's diseaseLewy body dementia
Source: ClinicalTrials.gov (NCT05676294). StuddyBuddy aggregates publicly available trial information.