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.
Up to 37% of patients undergoing ambulatory surgery experience postdischarge nausea and vomiting (PDNV), and PDNV represents a major barrier to improving a patient's quality of recovery. Because olanzapine has been shown to be an effective drug for PDNV prevention, but carries the risk of sedation, this study seeks to identify if the administration of olanzapine is an intervention that improves a patient's overall quality of recovery. The study population includes women between 18 and 50 years-old who are undergoing ambulatory (outpatient) surgery at Yale New Haven Hospital. This represents the population that is most susceptible to post-discharge nausea and vomiting (PDNV) and is therefore most likely to benefit from an intervention that reduces PDNV to impact overall quality of recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
384
5 mg of oral olanzapine one hour prior to ambulatory surgery
oral matched placebo one hour prior to ambulatory surgery
Yale New Haven Hospital
New Haven, Connecticut, United States
Quality of Recovery-40 (QoR-40) survey to assess efficacy
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Time frame: post-operative day 1
Quality of Recovery-40 (QoR-40) survey to assess efficacy
Quality of Recovery-40 (QoR-40) survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The survey is scored on a 5-point Likert scale: for positive items: 1 = none of the time, 5 = all of the time; for negative items, the scoring was reversed. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Time frame: post-operative day 2
Nausea
Presence of nausea on post-operative day 1 will be rated on a 0 to 10 numerical rating scale with 0 being "none" and 10 being "worst nausea imaginable"
Time frame: post-operative day 1
Nausea
Presence of nausea on post-operative day 2 will be rated on a 0 to 10 numerical rating scale with 0 being "none" and 10 being "worst nausea imaginable"
Time frame: post-operative day 2
Severe post-discharge nausea
Severe post-discharge nausea defined as any numerical rating \> 3 on a 0-10 scale during the 24 hours after discharge
Time frame: up to 24 hours post discharge
Recovery room length of stay
Recovery room length of stay in minutes
Time frame: From surgery end time to recovery room discharge, up to 23 hours
Recovery room opioid consumption
Recovery room opioid consumption in morphine milligram equivalents
Time frame: From surgery end time to recovery room discharge, up to 23 hours
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