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

Yale University

Status and phase: Completed; Phase 2

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Placebo; Drug: Olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT05676294

2000033786

No NIH funding (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 384 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Female aged 18-50
• Scheduled to undergo ambulatory surgery under general anesthesia
• Access to smartphone device or computer with internet connection and has an email address

Exclusion criteria

• Non-English speaking

• Unable to swallow pills

• Current use of anti-psychotic medications

• History of allergy to olanzapine

• Pregnancy/Lactation

• Current use of antihypertensive medication

• Diabetes Mellitus

• Clinically significant cardiovascular disease defined as follows:

  1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
  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.
  3. New York Heart Association Class II or higher congestive heart failure.
  4. Postural hypotension or vasovagal syncope within 6 months of planned surgery.

• Hypotension on day of surgery, defined as a systolic blood pressure < 90mmHg

• Seizure disorder

• Clinically active prolactinoma

• Hepatic disease

• Narrow angle glaucoma

• Parkinson's disease

• Lewy body dementia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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384 participants in 2 patient groups, including a placebo group

Olanzapine

Experimental group

Description:

olanzapine oral tablet, 5mg, once prior to surgery

Treatment:

Drug: Olanzapine

Placebo

Placebo Comparator group

Description:

placebo oral tablet once prior to surgery

Treatment:

Drug: Placebo