Today's pic:
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The second study that I participated in is titled: A Prospective Intercentional Study to Reduce Postoperative and Postdischarge Nausea and Vomiting in a High Risk Orthognathic Surgery Population (PONV for short).
What is the purpose of this study?
The purpose of this study is to study the experience orthognathic surgery patients like you have with nausea and vomiting after surgery, not only while still in the hospital but also during the first week at home after leaving the hospital. Our primary goal is to evaluate a protocol we have developed that will guide your care while in the operating room and while in the hospital. We believe this protocol will decrease the number of patients who experience nausea and vomiting after surgery and after leaving the hospital.
We know that patients who have orthognathic surgery, especially when the top jaw (maxilla) is operated on, have nausea and vomiting more often after surgery than do patients getting other types of surgery. In fact, at UNC, about 60% of patients undergoing this type of surgery experienced nausea and/or vomiting afterwards.
We have developed a protocol using medications and principles often used during anesthesia and post-operative care to try to decrease the chances that you will get nauseated or vomit after your surgery. None of these medications is experimental. Our protocol is based on studies that have worked very well for patients undergoing other types of surgery, and we believe it has the potential to help you, too.
Are there any reasons you should not be in this study?
You should not be in this study if:
- You have uncontrolled GERD or hiatal hernia
- You have chronic kidney disease stage III or greater
- You have prolonged QT interval (QTc > 460)
- You have a history of severe constipation, pre-existing chronic nausea or vomiting
- You are allergic to or have contraindications to protocol medications, which include scopolamine, midazolam, propofol, remifentanil, erythromycin, solumedrol, depomedrol, decadron, droperidol, ondansetron, ketorolac, Tylenol, Phenergan, and fentanyl
- You cannot read English
- You do not want to complete a daily diary for seven days after surgery
- You have glaucoma
- You have a seizure disorder
- You have a COPD (chronic obstructive pulmonary disease)
- You have a baseline high blood pressure (hypertension)
How long will your part in this study last?
This study will take place in the hospital and at the Oral and Maxillofacial Surgery Clinic at UNC. Total time will be roughly 10 day after surgery (the exact number of days will vary depending on how long you stay in the hospital after surgery, typically 1 to 3 days).
While in the hospital, you will be asked about nausea and vomiting by the surgery, nursing, and anesthesia teams. This will take a total of 5-10 minutes daily each day you remain in the hospital.
After you go home from the hospital, you will be asked to complete a daily diary for one week. Each day's diary entry will take about 5 minutes. You will bring this diary to your next postoperative visit after completion of the diary or you may mail the diary to us in a pre-paid envelope.
What will happen is you take part in the study?
When you undergo anesthesia, a special protocol will be followed. An IV will be started before surgery, which is what usually happens even if not in the study. The protocol will guide the medications you will receive and the amount of fluid that you receive in your IV. The protocol is based on prior research studies that show similar protocols reduce nausea and vomiting after surgery.
After surgery, you will receive several pain medications both by mouth and through your IV. Some of these medications are intended to decrease your need for opioid pain medications like codeine and hydrocodone as these have been shown to increase nausea and vomiting.
After you leave the hospital, you will be asked to complete a diary every evening for one week. You may feel uncomfortable about answering some of the questions on the questionnaires. You are free not to answer any of those questions.
In addition, there may be uncommon or previously unknown risks that might occur. You should report any problems to the researchers.
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. The benefits to you from being in this study may be a decrease in the chance that you get nauseated or throw up after the surgery.
What are the possible risks or discomforts involved from being in this study?
Any time you undergo general anesthesia, there is a very small risk that you could remember what happened while you are asleep. This risk is minimally increased with a total intravenous anesthetic, which you will receive in this study. To reduce this risk, you will be monitored closely by your anesthesia care team throughout your surgery for signs that you need additional anesthesia medicine. Another thing that reduces your risk of this very rare event after general anesthesia is that you will not need to be paralyzed throughout your surgery; this gives the anesthesia team another sign to monitor to reduce your risk of awareness. If you experience awareness, tell us immediately so we can help you access resources to process and recover from awareness.
Any time you receive medications there are risks of side effects or allergic reactions. This is true whether you participate in the study or not. You will be monitored while receiving medications and will be treated as indicated if side effects/allergic reactions develop. Please note that erythromycin can sometimes cause nausea or vomiting; however, the investigators feel that it is more likely to reduce than to increase nausea and vomiting in your situation.
We have carefully set up our data storage with advice from the Information Technology services at UNC to maximize data security. However, there is a small risk that information collected in the study could be lost. If this occurs, we will inform you of the breach and work with Information Technology to recover data/restore security.
There may be uncommon or previously unknown risks. You should report any problems to the researcher.
