An interventional study of Antiemetic anesthesia protocol in Post-operative Nausea, Post-operative Vomiting and Nausea Persistent, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2014-08-20.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
The purpose of this study is to determine whether a multi-modal anesthesia and pain control protocol reduces post-operative and post-discharge nausea and vomiting (PONV and PDNV) in patients undergoing upper jaw corrective surgery.
Post-operative and post-discharge nausea and vomiting (PONV and PDNV) plague post-anesthesia and surgical care. This fact remains especially true for the orthognathic surgery (OS) population undergoing procedures involving the maxilla. Current data estimate that the incidence of PONV for OS patients undergoing surgery involving the maxilla is between 44% and 68% as compared to 8% to 30% in general surgical populations, despite application of conventional therapies. No one has accounted for or addressed this difference in clinical outcomes.
The implications of PONV for both individual health and overall health care system function are considerable. For individual patients, PONV can result in dehydration, wound dehiscence, intra-oral bleeding with continued swallowing of blood, significant anxiety and agitation (particularly for OS patients who often have heavy elastics closing their jaws together after surgery), and, in extreme cases, esophageal damage or the risk of pulmonary aspiration. Evidence shows fear of PONV overshadows concerns about pain in surgical patients. At the health care system level, evidence suggests PONV can significantly increase health care costs through prolonged post-anesthesia care unit (PACU) stays and unplanned hospital admissions following outpatient procedures. In one seminal study the odds ratio for unplanned admission due to vomiting after intended outpatient surgery was 3.4, an alarmingly high figure exceeded only by the odds ratios for readmission due to pain or bleeding.
Established patient-related risk factors for PONV include female gender, tobacco abstinence, and history of prior PONV or motion sickness; additional patient factors may include younger age, low American Society of Anesthesiologists Physical Status Classification System status, anxiety, and a migraine headache history. Known anesthesia technique-related risk factors include volatile anesthetic and nitrous oxide use as well as excessive IV opioid administration. High dose neuromuscular blockade reversal agents have also been implicated. Surgery-related factors include duration of surgery and type of surgery, with OS ranking among the high-risk types.
Because PONV (and PDNV) prevention and treatment for the OS population remain under-investigated domains of clinical care, the investigators seek to address this deficiency through multi-modal prophylactic therapy. As more OS procedures are performed, many on an ambulatory basis, tactics to reduce the high incidence of PONV in this surgical population become important to maximize patient safety and satisfaction and to contain costs.
The investigators' protocol will synthesize several recommendations to reduce risk of PONV. Volatile anesthetics and nitrous oxide will be avoided in favor of a total intravenous (IV) anesthetic involving propofol, neostigmine will be minimized, hydration goals will be set, and opioid sparing analgesics will be utilized. It is recommended that patients at high risk for PONV receive combination therapy with prophylactic agents from multiple classes. Among those shown to reduce PONV are 5-HT3 receptor antagonists (such as ondansetron), droperidol, and dexamethasone. Transdermal (TD) scopolamine is another effective adjunctive therapy to reduce PONV. Additionally, the investigators posit that the constant swallowing of small amounts of oozing blood and its retention in the stomach following OS contribute to the high incidence of PONV and PDNV in the OS population. Thus sub-bacteriostatic doses of erythromycin, capitalizing on erythromycin's established properties as a motilin agonist and thus a pro-kinetic, will be added to the evidence-based multi-modal regimen. Erythromycin has been chosen over metoclopramide due to safety profile and its well-characterized impact on gastric motility and even PONV.
Rescue anti-nausea and anti-emetic therapy will be chosen from several options at the discretion of the treating physician. Options that work through several mechanisms have been selected based on the Society of Ambulatory Anesthesia Guidelines and on data from a randomized, double-blind, placebo-controlled study of over 2000 subjects.
Anesthesia variables as well as post-operative analgesic regimens are the primary targets of the investigators' multimodal regimen. Multimodal therapy has been shown to be superior to single agent therapy. One particularly compelling example showed a 98% response rate (no PONV) vs 76% among those receiving mono-therapy and 59% receiving routine anesthesia with placebo. Despite these reported successes, PONV remains a major problem for patients undergoing OS and many other procedures. This study represents one step towards understanding and addressing this significant peri-operative problem.
This proposed study will compare a cohort receiving a multimodal regimen with a retrospective control cohort reviewed in an IRB-approved study at the same institution. The investigators' re-use of the data adds no risk of harm or disclosure to the control subjects. Utilization of this retrospective control has an important advantage over a concurrent control: It allows comparison to a group treated at the same institution without the potential introduction of bias by alerting practitioners to the extent of the PONV problem in OS. The investigators believe that, as the under-recognition of the OS group as high-risk likely contributes to the high rate of PONV these patients experience, education of the anesthesia community introduces a potential confounding variable. Further, comparing practice "as is" to the proposed protocol maximizes generalizability to other institutions. If, as anticipated, significant reductions in PONV and PDNV experience are found, prospective randomized trials to tease out nuances of contributing factors could be undertaken.
Potential influencing patient- and surgery-related variables will be collected to allow comparison of the two cohorts using logistic regression analyses.
Even less well understood than PONV is PDNV; additional studies are needed to deepen understanding of the risk factors and treatment options for PDNV. A prior study from the investigators' institution demonstrated a high incidence of PDNV in the OS population - 43% experienced nausea and 23% vomited after discharge in contrast to general reported rates of 17% PDN and 8% PDV. This study should offer additional insight into PONV's less understood counterpart through diary review of patient's self-reported experience of PDNV following discharge from direct medical supervision.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 233 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Scopolamine 1.5 milligram(mg) patch Propofol infusion remifentanil infusion 250mg erythromycin po for 2 doses Solumedrol 0.625mg IV droperidol 4mg IV Ondansetron Ketorolac 30mg IV ibuprofen 600mg po q6h Fentanyl Hydrocodone/Tylenol po
Other: Antiemetic anesthesia protocol
Intervention group consisted of patients undergoing maxillary osteotomy who received an antiemetic protocol designed to provide multimodal antiemetic therapy which have been shown to help prevent and/or treat postoperative nausea, combined with the elimination of anesthetic factors that may contribute to postoperative nausea and vomiting.
Also known as: Scopolamine 1.5 milligram(mg) patch, Propofol infusion, remifentanil infusion, 250mg erythromycin po for 2 doses, Solumedrol, 0.625mg IV droperidol, 4mg IV Ondansetron, Ketorolac 30mg IV, ibuprofen 600mg po q6h, Fentanyl, Hydrocodone/Tylenol po
Post-operative Nausea
End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.
Time frame: End of surgery to discharge from hospital
Post-operative Vomiting
Time frame: End of surgery to discharge from hospital
Hospital Length of Stay
Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.
Time frame: Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours
Post-discharge Nausea
To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital
Time frame: 1 week from discharge from hospital
Post-discharge Vomiting
Time frame: 1 week post discharge
| Milestone | Intervention Cohort | Comparison Cohort |
|---|---|---|
| Started | 96 | 137 |
| Completed | 93 | 137 |
| Not completed | 3 | 0 |
| Withdrew: Protocol violation | 3 | 0 |
End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.
| percentage of subjects with PON | Intervention Cohort | Comparison Cohort |
|---|---|---|
| Post-operative Nausea | 24 | 70 |
Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.
| hours | Intervention Cohort | Comparison Cohort |
|---|---|---|
| Hospital Length of Stay | 26.4 (23.5 to 32.6) | 28.2 (23.5 to 41.4) |
To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital
| percentage of subjects with PDN | Intervention Cohort | Comparison Cohort |
|---|---|---|
| Post-discharge Nausea | 72 | 60 |
| percentage of subjects with POV | Intervention Cohort | Comparison Cohort |
|---|---|---|
| Post-operative Vomiting | 11 | 28 |
| percentage of subjects with PDV | Intervention Cohort | Comparison Cohort |
|---|---|---|
| Post-discharge Vomiting | 22 | 29 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Cohort | — | 0/93 (0%) | 0/93 (0%) |
| Comparison Cohort | — | 0/137 (0%) | 0/137 (0%) |
| Age, Continuous(years) | Intervention Cohort | Comparison Cohort | Total |
|---|---|---|---|
| Median | 20 (17 to 24) | 19 (17 to 23) | 19 (17 to 23) |
| Sex: Female, Male(Participants) | Intervention Cohort | Comparison Cohort | Total |
|---|---|---|---|
| Female | 54 | 89 | 143 |
| Male | 39 | 48 | 87 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill