Prospective, Double Blind, Placebo Control, Bariatric IV Ace
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/22/2018 |
| Start Date: | February 2016 |
| End Date: | January 2017 |
Prospective, Double Blind, Placebo Control, Study of Acetaminophen iv on Hospital Length of Stay in Morbidly Obese Individuals Undergoing Elective Laparoscopic Sleeve Gastrectomy
The purpose of this study is to determine if the administration of acetaminophen given
intravenously (through an IV) beginning during surgery and then for 3 additional doses during
the first 24 hours post-operatively will reduce the length of time subjects undergoing
elective sleeve gastrectomy spend in the hospital following this operation. Additional
questions that may be answered include whether administration of the study medication leads
to improvement in pain control, a reduction in post-operative nausea and vomiting, and an
overall improvement in quality of recovery.
intravenously (through an IV) beginning during surgery and then for 3 additional doses during
the first 24 hours post-operatively will reduce the length of time subjects undergoing
elective sleeve gastrectomy spend in the hospital following this operation. Additional
questions that may be answered include whether administration of the study medication leads
to improvement in pain control, a reduction in post-operative nausea and vomiting, and an
overall improvement in quality of recovery.
Morbid obesity is defined as a body mass index (BMI: weight [kg] / height [m]2) ≥ 40 or ≥ 35
if associated with comorbidities, and it is widely prevalent, nationally and globally.
Overweight or obese individuals have increased morbidity and mortality. Among the many
available treatment options, surgical management of obesity has been shown to be the most
reliably effective in achieving sustained weight loss and improvements in glycemic,
lipidemic, and blood pressure control, and improves five and ten year survival in contrast to
matched controls who did not have surgery. Various surgical approaches have been used to
provide long-term control of morbid obesity and its associated comorbidities, including
laparoscopic sleeve gastrectomy.
During a sleeve gastrectomy the greater curvature of the stomach is separated from the lesser
curvature and antrum, thereby eliminating ~85% of the total stomach, including the
grehlin-producing portion of the stomach. A common complication of the procedure is
postoperative nausea and vomiting (PONV), occurring in nearly 80% of patients undergoing the
procedure. Risk factors for PONV include: female sex, history of PONV or motion sickness,
nonsmoking, younger age, general vs. regional anesthesia, use of volatile anesthetics and
nitrous oxide, administration of postoperative opioids, duration of anesthesia, and type of
surgery (including cholecystectomy, laparoscopic, and gynecological). At the individual
level, PONV adversely impacts both patient satisfaction and quality of life scores. At the
systems level, PONV is associated with increased length of stay (LOS) in the post-anesthesia
care unit and hospital, and can result in increased costs.
Both pharmacological and surgical approaches have been studied in an effort to reduce the
incidence of PONV in sleeve gastrectomy patients. Omentopexy was unsuccessful, and
pharmacologic prophylaxis with two [dexamethasone + odansetron; dexamethasone + granisetron;
aprepitant + odansetron; or three (dexamethasone + odansetron + haloperidol; antiemetic
agents was more effective than a single agent (odansetron or granisetron) alone in decreasing
both nausea and vomiting. Even with triple therapy, just over 50% of patients were nauseous
and 20% vomited within the first 36 hours following surgery, and hospital LOS was unaffected.
Thus, there is a pressing need for improved control of PONV in sleeve gastrectomy patients.
Acetaminophen (N-(4-hydroxyphenyl)acetamide; paracetamol) is a mild analgesic whose main, but
not sole, mechanism of action is thought to arise from inhibition of the cyclooxygenase
pathway; the intravenous (iv) formulation (acetaminophen iv; ACP-iv) received US Food and
Drug Administration (FDA) approval in November 2010 but has been available in Europe since
2002. It is approved by the FDA for the management of mild to moderate pain as a single agent
and the management of moderate to severe pain with adjunctive opioid analgesics. Recently,
two meta-analyses have evaluated the use of ACP-iv in the postoperative period for its
efficacy in preventing postoperative pain [45] or reducing PONV [46]. In the study by De
Oliveria et al., ACP-iv administration was found to significantly reduce postoperative pain,
opioid consumption, and PONV. Similarly, the study by Apfel and colleagues indicated that
iv-ACP, when administered prophylactically, reduced PONV as a consequence of improved pain
control. With direct relevance to sleeve gastrectomy patients, a retrospective analysis of
patients undergoing bariatric surgery (sleeve gastrectomy or laparoscopic Roux-en-Y gastric
bypass) found that ACP-iv administration reduced opiate consumption and hospital LOS.
The investigators hypothesize that administration of ACP-iv in the perioperative period will
reduce hospital LOS in sleeve gastrectomy subjects and will be associated with a reduction in
hospital costs. The secondary hypothesis is that administration of ACP-iv will reduce PONV
and improve subject satisfaction scores in the same subject population.
if associated with comorbidities, and it is widely prevalent, nationally and globally.
Overweight or obese individuals have increased morbidity and mortality. Among the many
available treatment options, surgical management of obesity has been shown to be the most
reliably effective in achieving sustained weight loss and improvements in glycemic,
lipidemic, and blood pressure control, and improves five and ten year survival in contrast to
matched controls who did not have surgery. Various surgical approaches have been used to
provide long-term control of morbid obesity and its associated comorbidities, including
laparoscopic sleeve gastrectomy.
During a sleeve gastrectomy the greater curvature of the stomach is separated from the lesser
curvature and antrum, thereby eliminating ~85% of the total stomach, including the
grehlin-producing portion of the stomach. A common complication of the procedure is
postoperative nausea and vomiting (PONV), occurring in nearly 80% of patients undergoing the
procedure. Risk factors for PONV include: female sex, history of PONV or motion sickness,
nonsmoking, younger age, general vs. regional anesthesia, use of volatile anesthetics and
nitrous oxide, administration of postoperative opioids, duration of anesthesia, and type of
surgery (including cholecystectomy, laparoscopic, and gynecological). At the individual
level, PONV adversely impacts both patient satisfaction and quality of life scores. At the
systems level, PONV is associated with increased length of stay (LOS) in the post-anesthesia
care unit and hospital, and can result in increased costs.
Both pharmacological and surgical approaches have been studied in an effort to reduce the
incidence of PONV in sleeve gastrectomy patients. Omentopexy was unsuccessful, and
pharmacologic prophylaxis with two [dexamethasone + odansetron; dexamethasone + granisetron;
aprepitant + odansetron; or three (dexamethasone + odansetron + haloperidol; antiemetic
agents was more effective than a single agent (odansetron or granisetron) alone in decreasing
both nausea and vomiting. Even with triple therapy, just over 50% of patients were nauseous
and 20% vomited within the first 36 hours following surgery, and hospital LOS was unaffected.
Thus, there is a pressing need for improved control of PONV in sleeve gastrectomy patients.
Acetaminophen (N-(4-hydroxyphenyl)acetamide; paracetamol) is a mild analgesic whose main, but
not sole, mechanism of action is thought to arise from inhibition of the cyclooxygenase
pathway; the intravenous (iv) formulation (acetaminophen iv; ACP-iv) received US Food and
Drug Administration (FDA) approval in November 2010 but has been available in Europe since
2002. It is approved by the FDA for the management of mild to moderate pain as a single agent
and the management of moderate to severe pain with adjunctive opioid analgesics. Recently,
two meta-analyses have evaluated the use of ACP-iv in the postoperative period for its
efficacy in preventing postoperative pain [45] or reducing PONV [46]. In the study by De
Oliveria et al., ACP-iv administration was found to significantly reduce postoperative pain,
opioid consumption, and PONV. Similarly, the study by Apfel and colleagues indicated that
iv-ACP, when administered prophylactically, reduced PONV as a consequence of improved pain
control. With direct relevance to sleeve gastrectomy patients, a retrospective analysis of
patients undergoing bariatric surgery (sleeve gastrectomy or laparoscopic Roux-en-Y gastric
bypass) found that ACP-iv administration reduced opiate consumption and hospital LOS.
The investigators hypothesize that administration of ACP-iv in the perioperative period will
reduce hospital LOS in sleeve gastrectomy subjects and will be associated with a reduction in
hospital costs. The secondary hypothesis is that administration of ACP-iv will reduce PONV
and improve subject satisfaction scores in the same subject population.
Inclusion Criteria:
- At least 18 years old
- BMI > 30
- Undergoing Elective Sleeve Gastrectomy
- Able to consent
Exclusion Criteria:
- Allergy/ Hypersensitive to acetaminophen or formulation incipients
- Allergy/Hypersensitive to aprepitant, ondasteron (serotonin type 3 receptor
antagonists), dexamethasone
- Allergy to Propofol or formulation incipients (egg albumin, soy lecithin)
- Diagnosis or positive family history of malignant hyperthermia
- Abnormal LFTs (AST and ALT) >2x local upper limits of normal
- Renal impairment (creatinine clearance (CrCl) ≤ 30mL/min adjusted for obesity))
- Pregnancy
- Alcohol consumption > 3 drinks/day
- Requires awake intubation
- Unable to provide consent
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