Postoperative Nausea and Vomiting: 168 Years in Review-Juniper Publishers
Juniper Publishers-Journal of Anesthesia
Abstract
DiLustro is the inventor of the multi-modal PONV
Pressure Point therapy technique. Research and expanding use of this
technique has proven to be a safe and effective multi-modal choice in
PONV management. The company's acu-stimulation adhesive technique
enhances anesthesiology benefits, such as, nausea and vomiting
prophylaxis, elimination of expensive or risk-based rescue drug
therapies and broader patient satisfaction, with no reported adverse
effects. This evidence-based anesthetic-related technique provides an
extended duration (72 hours) of PONV therapy to support Enhanced
Recovery after Surgery (ERAS) protocol reimbursement practices.
Introduction
The introduction of volatile agents such as ether and
chloroform in the 1840s was heralded as the most important medical
innovation. However, the phenomenon of postoperative nausea and vomiting
(PONV) became evident within only two years, and remains as a major
complication for general anesthesia today. The first report on the
devastating effect of PONV was published in 1848 by Dr. John Snow, a
British anesthesiology pioneer who described his findings on this
disturbing complication associated with surgery and anesthesia. Until
his untimely death in 1858 at the age of 45 years, Dr. Snow was one of
the foremost authorities in the administration of anesthesia [1].
During the ether era of 1846 to 1950, the incidence of PONV was reported to be as high as 75-80% [2].
During this time in an effort to reduce the incidence of PONV,
neuroleptic drugs were considered the most efficacious pharmacotherapy
because of the inherent anti-emetic properties of this drug class. The
first prophylactic use of an anti-emetic drug derived from the
neuroleptic phenothiazine drug class was introduced in the 1880s [2].
Neuroleptic phenothiazine drugs block receptors in the central nervous
system's (CNS) dopamine pathways which mitigate the effects of nausea.
The Emergence of Anti-Emetic Therapy
Almost half a century later, the use of new
neuroleptic class of promethazine drugs emerged to further reduce the
incidence of PONV [3].
Promethazine pharmaceuticals have profound anti-emetic properties due
to antagonizing histamine-1 receptors in the CNS. However, because of
untoward sedative effects, the use of this drug class was very limited
for postoperative antiemetic prophylaxis because it delayed emergence
from general anesthesia. Twenty years later, the next phase of
anti-emetic therapy emerged. The neuroleptic class of chlorpromazine
drugs antagonized a variety of receptors in the CNS.3 Unfortunately the
drug's neuroleptic effect elicits both sedation and hypotension which
limited its use in PONV management.
The First Century of Anti-Emetic Therapy
After the discovery of anesthetic-induced PONV,
clearly the distress of surgical patients were not positive experiences
evidenced during the first 100 years ofthe practice of medicine. By
1950, anesthesia practice changed to reduce the residual effects of
drugs that contributed to PONV. Six years later, halothane, a
non-flammable volatile gas developed for general inhalational anesthesia
was introduced, replacing noxious anesthetics such as ether. Halothane
contributed to a substantially-reduced PONV incidence after emergence
from inhalational general anesthesia. Over the next 25 years, halothane
was commonly administered in clinical anesthesia practice [4].
During the 1980s in the US, the administration of these early
inhalational anesthetic agents became less appealing and were gradually
phased out as improved volatile agents were developed such as
isoflurane, desflurane, or sevoflurane.
Evolution of PONV Prophylaxis
At the end of the 20th century, advancements in the
prophylactic use of anti-emetic drug therapy had not progressed mainly
because of the serious risks of drug side effects such as profound
sedation. In the early 1990s, anesthetists preferred a novel anesthetic
agent: propofol. This hypnotic drug is administered intravenously (IV)
as an induction drug or total IV delivery for anesthetic maintenance. In
addition, IV propofol has anti-emetic properties that help reduce the
effects of PONV [4]. Propofol is still today's choice as a general anesthetic agent in contemporary anesthesia practice.
Novel Anti-Emetics
Fortunately, in the mid-1990s, anesthesiologists focused on the promising new class of anti-emetics, the 5-HT3-serotonin
receptor antagonists introduced to oncologists for the treatment of
chemotherapy-induced nausea and vomiting (CINV). These drugs block the
5-HT3-serotonin receptors, which are highly- specific
emetogenic receptors in the chemoreceptor trigger zone (CTZ).
Clinically, the 5-HT3-receptor antagonists produced an anti-emetic effect with little to no side effects, with a relatively good safety profile [5].
Since the mid-1990s, the traditional anti-emetic
therapy chosen by most anesthesiologists and certified registered nurse
anesthetists (CRNAs) to mitigate the incidence of PONV, include the
serotonin 5-HT3-receptor antagonists such as ondansetron
(Zofran®), granisetron (Kytril®) or dolasetron (Anzemet®). In addition,
anesthesiologists and CRNAs use a multi-modal strategy that includes
dexamethasone, a steroid drug that is known to have anti-emetic
properties to enhance the efficacy of 5-HT3 prophylactic
therapy. Due to multiple emetic receptors that can be stimulated during
anesthesia, the management of PONV requires multi-modal strategies using
a combination of antiemetic drugs to help ameliorate PONV such as 5-HT3-receptor antagonists, especially in the high-risk patient population [5]. These type of anti-emetics help block the serotonin receptors throughout the gut and CNS that trigger nausea and vomiting.
Short Duration of PONV Prophylaxis Efficacy
Much evidence published over the last 15 years describes the limited efficacy and duration of action of the traditional 5-HT3-receptor
antagonists, including dexamethasone used in a multi-modal anti-emetic
therapy regimen. Initially anesthetists thought that 5-HT3
antagonists should be preemptively administered, prior to the induction
of anesthesia. However, because of the drug's relatively short duration
of PONV efficacy, later practice evolved to administer prophylaxis just
prior to emergence of anesthesia, at the completion of surgery during
patient skin closure.
Comparatively, the traditionally standard use of 5-HT3-
receptor antagonists, such as ondansetron (or in combination with
dexamethasone), currently offer some PONV prevention as well as a higher
safety profile compared to other prophylactic drugs. Despite the import
of the evidence-based practice of multimodal anti-emetic drug
prophylaxis, some surgical patients continue to experience protracted
PONV symptoms which can also interfere with patients' recovery at home
especially after outpatient surgery [6-8].
Clinically, an estimated 25%-30% of surgical patients are still
impacted by PONV after general anesthesia subsequent to receiving
prophylactic anti-emetic medications [9].
In addition, one-third or even up to 35%-49% of patients undergoing
outpatient surgery experience nausea and vomiting after they are
discharged. Largely because patients returning home from outpatient
surgery do not have access to anti-emetic therapy [9,10].
Expanding Anti-Emetic Therapy
The relatively new phenomenon known as post-discharge
nausea and vomiting (PDNV) has become a significant concern to
practitioners because of the growing number of outpatient and short-stay
surgical procedures. Anesthesiologists, CRNAs, and especially
peri-operative nurses continue to be confronted with patients’
complications of PONV and PDNV, despite modifying dosages or
combinations of anti-emetic therapy
After discharge from outpatient surgery, extended
antiemetic benefits are not solving the PDNV problem at home.7 Clinical
options for achieving anti-emetic efficacy in the postdischarge period
include newer anti-emetics which are either very expensive, such as
aprepitant (Emend®), palonesetron (Aloxi®), or transdermal scopolamine [11].
However, the scopolamine patch may have the potential of temporarily
imposing adverse quality of life issues (i.e., blurred vision or
extremely dry mouth) [12].
Enhancing patient satisfaction, providing
cost-benefits and minimizing drug side effects are paramount for a
worthy solution to the recalcitrant PONV problem. Use of other
clinically- developed multi-modal PONV techniques that enable patients
to overcome the anesthetic-induced difficulties associated with surgery
can become part of a novel and efficacious multi-modal prophylaxis
strategy for anti-emesis [13].
Effective emetic prophylaxis management today
requires refinement for at-risk surgical patients who require enhanced
protection against the episodic severity of further PONV and PDNV
suffering. Current published PONV guidelines require an upgrade of
additional PONV techniques to mitigate the effects of both
post-operative problems. Over the last 15 years, evidence reveals that
prophylactic drug therapy alone is not the complete solution in
substantially preventing the incidence of PONV and PDNV. The PONV
guidelines offer strategic insight into identifying at-risk surgical
patients. However, the existing prophylactic multi-modal drug treatment
strategy model has not resulted in a complete effect of a clear and
definitive solution to extensively improving patient recovery from
deleterious nausea and vomiting in the post-operative period [13].
The legacy of PONV prophylaxis today is compounded by
the growing concern of PDNV occurrences at home for surgical patients.
The implication for expanded anti-emetic coverage is readily apparent in
view of current clinical PONV/PDNV events. Additional multi-modal PONV
techniques are currently available to fill the vacuum of patient need
due to inadequate efficacy of drug therapy. Clinically-proven and FDA
approved prescription and/or over-the-counter (OTC) main stream,
multi-modal PONV techniques implemented as part of the multi-modal
anesthetic plan, would serve to improve overall PONV management
conditions
The clear implication is that intervention other than
further pharmacotherapy is necessary to reduce nausea and vomiting
symptoms for surgery patients. Other clinically-proven, main stream
multi-modal PONV techniques lead these efforts. Clearly a fundamental
serious reevaluation is necessary to achieve an enhanced quality of PONV
outcomes management compared to drug treatment options alone [13].
PONV Pressure Point Therapy
Pressure Point, Inc. is a global medical
device company specializing in mainstream acu-point stimulation strips,
which improve multi-modal anesthetic techniques associated with the
complexity common problem of post-operative nausea and vomiting. The
company introduced its Pressure Right© acupressure
point-stimulation product in 2011 after receiving market clearance from
the FDA as a prescribed technique representing an essential part of the
anesthetic plan for surgery patients. In 2014, Pressure Point
subsequently received market clearance as an OTC technique for the
prevention of nausea and vomiting.
As part of a multi-modal strategy for patients
undergoing laparoscopic surgery, a high quality, randomized,
double-blind, sham-controlled study reported that the use of Pressure
Right© demonstrated a statistically meaningful, absolute risk reduction
of PONV for surgical patients as long as 72 hours postoperatively [14]. The study further confirmed the direct result of prophylaxis with Pressure Right©
revealed a multi-modal PONV effect to substantially reduce the main
stream requirements for expensive rescue-drug therapies. As a result, a
broader patient satisfaction with PONV prevention was reported among
Pressure Right© study subjects.
Prior to the introduction of the multi-modal Pressure
Right© acu-stimulation strip in 2011 for the 72-hour prevention of
PONV, a plethora of research had been published on the efficacy of
acu-stimulation for PONV [14-16].
Several incipient versions of acu-stimulation offered significant
benefits and few, if any risks. However, the early product models were
limited in duration for multi-modal nausea prophylaxis for surgical use
and patient suitability for PONV prevention.
Pressure Right's® adaptive adhesive technique
uses 3M™ material that's been on the market since 1970, which is safe
from skin irritation, blistering, or pain when applied to the skin for
extended use.
The Pressure Right® randomized, double-blind, sham-
controlled study effectively combined PC6 acustimulation and PONV
antiemetic therapy versus antiemetic therapy and demonstrated improved
PONV patient outcomes despite the use of an insensitive binary method
(Yes or No) study response to assess postoperative nausea [14].
In a recent Cochrane review of PC6 acustimulation
clinical data of at least 39 trials, 4622 participants, compared to sham
treatment, it confirmed PC6 acustimulation techniques significantly
reduced the incidence of nausea, vomiting and the need for rescue
antiemetics postoperatively. The Cochrane author’s conclusion recommends
more high-quality trials involving the combination of acustimulation
and antiemetic drug therapy compared to drug prophylaxis to determine
the combination’s clinical PONV therapy future impact [17].
Outside the US today, Pressure Point© has overseas
distribution partners targeting the anesthetic market for prevention of
PONV for at-risk surgical patients. Research and expanding use has
proven Pressure Right© a high-quality competitive choice in PONV
management.
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