PONV Clinical Trial
Official title:
Randomized Double Blind Study to Evaluate the Efficacy of IV Palo w/ IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed Post-Operative Nausea/Vomiting in Subj Undergoing Laparoscopic Surgeries w/a High Emetogenic Risk
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.
Post-operative nausea and vomiting (PONV) is a frequent complication of surgery, with
considerable medical and economic impact. It is also associated with high levels of patient
discomfort and dissatisfaction. To many patients, PONV is a distressing event that
reportedly is more feared than post-operative pain. The cause of PONV is complex and can be
due to multiple factors. These factors may include certain characteristics of the patient
(such as female gender, non-smoking status, and having experienced PONV in the past), the
surgical procedure (intra-abdominal laparoscopic procedures, gynecologic surgeries, breast
surgeries), and the type of anesthetic that is used. Untreated, the incidence of
post-operative nausea and vomiting (PONV) in high risk patients can reach 70-80%. In
addition, it is important to note that PONV can present during the first 24 hours after
surgery or beyond. PONV alone is one of the leading causes for delayed discharge and
unplanned hospital admission following outpatient surgery. Furthermore, more than 35% of
surgical outpatients experience PONV following discharge, many of whom did not experience
nausea or vomiting in the recovery room.
An important factor in the development of Post-operative nausea and vomiting (PONV) appears
to be the release of the biogenic amine serotonin (5-HT3) in the brainstem and the
peripheral nervous system. Serotonin induces nausea and vomiting via the 5-HT3 receptor.
Currently, medications that block the 5-HT3 receptor are widely accepted as a first-line
anti-emetic in both the prevention and treatment of PONV. Ondansetron is the most commonly
prescribed. An intra-venous dose of Ondansetron administered intra-operatively is predicted
to reduce PONV by 15-20% when compared to patients who receive a placebo. However,
Ondansetron has a half-life of approximately six hours and must be re-dosed in patients with
prolonged or delayed-onset PONV.
By contrast, Palonosetron is another 5-HT3 receptor antagonist that has a longer half-life
than Ondansetron, thus reducing the need for re-dosing; a single dose of Palonosetron was
shown to be superior to a single dose of Ondansetron in the treatment of delayed nausea and
vomiting associated with chemotherapy.
Furthermore, there is now evidence that a multimodal approach to the prevention of
post-operative nausea and vomiting is more effective than any single medication. A recent
study determined that a combination regimen of Ondansetron and Dexamethasone (a steroid
medication known to prevent nausea and vomiting) provided significantly better prophylaxis
against PONV than Ondansetron alone.
Therefore, the rationale for conducting this study is to evaluate whether the administration
of a single dose of Palonosetron combined with Dexamethasone is superior to a single dose of
Palonosetron alone in the prevention of both immediate and delayed PONV in high risk
patients undergoing laparoscopic abdominal or gynecologic surgery.
In order to answer the question of whether Palonosetron plus Dexamethasone is significantly
more effective at reducing the incidence of PONV than Palonosetron alone, we will enroll
patients that are high risk for PONV who are undergoing laparoscopic abdominal or
gynecologic surgery. This subset includes: female patients, non-smokers, and patients with a
history of PONV.
Each study patient will receive Palonosetron alone or Palonosetron plus Dexamethasone
immediately prior to the start of her/his surgery. We will then use an 11 point nausea scale
to determine how many patients had a complete response to the medication (complete response
= NO nausea and NO vomiting at any time during the study period of 0-72 hours post surgery).
If a patient does experience nausea or vomiting, we will record the time and severity of the
PONV as well as whether any medication was given to relieve the nausea and vomiting. If a
patient is discharged from the hospital before their 72nd hour post surgery, (s)he will
receive a journal in which to record any symptoms or nausea or vomiting and a member of the
research team will call to obtain the information.
We predict that the combination of Palonosetron plus Dexamethasone will be superior to
Palonosetron alone in the prevention of PONV. We will compare the incidence of patients with
a complete response to the study medication (NO nausea and NO vomiting for 72 hours post
surgery) to determine if this hypothesis is valid.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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