COMPLETED

The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Impact of Pre-operative Olanzapine on Quality of Recovery-40 Scores After Discharge From Ambulatory Surgery

Quick Facts

Study Start:2023-06-26
Study Completion:2025-12-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05676294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Female aged 18-50
  4. * Scheduled to undergo ambulatory surgery under general anesthesia
  5. * Access to smartphone device or computer with internet connection and has an email address
  1. * Non-English speaking
  2. * Unable to swallow pills
  3. * Current use of anti-psychotic medications
  4. * History of allergy to olanzapine
  5. * Pregnancy/Lactation
  6. * Current use of antihypertensive medication
  7. * Diabetes Mellitus
  8. * Clinically significant cardiovascular disease defined as follows:
  9. 1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
  10. 2. 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.
  11. 3. New York Heart Association Class II or higher congestive heart failure.
  12. 4. Postural hypotension or vasovagal syncope within 6 months of planned surgery.
  13. * Hypotension on day of surgery, defined as a systolic blood pressure \< 90mmHg
  14. * Seizure disorder
  15. * Clinically active prolactinoma
  16. * Hepatic disease
  17. * Narrow angle glaucoma
  18. * Parkinson's disease
  19. * Lewy body dementia

Contacts and Locations

Principal Investigator

Jaime Hyman, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Hospital
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Jaime Hyman, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-26
Study Completion Date2025-12-06

Study Record Updates

Study Start Date2023-06-26
Study Completion Date2025-12-06

Terms related to this study

Keywords Provided by Researchers

  • olanzapine
  • placebo-controlled
  • nausea
  • vomiting
  • ambulatory surgery procedures
  • antiemetic
  • general anesthesia

Additional Relevant MeSH Terms

  • Postoperative Nausea and Vomiting