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This study is a prospective randomized clinical controlled trial testing the effects of pre-operative >50 g pre-operative carbohydrate fluids (apple juice) on a patient's post-operative nausea and vomiting (PONV) incidence and intensity. Optimizing fluid therapy in the peri-operative setting has been proven to improve patient outcomes and reduce complications and length of hospital stay. Based on practice guidelines under the American Society of Anesthesiologists, pre-operative hydration with complex carbohydrate drinks is safe and should be encouraged as it helps with improving metabolism to an anabolic state, decreases insulin resistance, reduces anxiety, and reduces PONV. While pre-operative carbohydrate (CHO) fluids have already been studied and adopted by other surgical specialities (Vascular, General Surgery, Orthopaedics, etc.), this has not yet been studied in oral and maxillofacial surgery, especially at Boston Medical Center (BMC).
During surgery, each participant will undergo our current Enhanced Recovery After Surgery "ERAS" protocol, which includes general anesthesia using inhalational gas, judicious IV fluids, intra-operative steroid and ondansetron (anti-emetic), use of 0.5% bupivacaine local anesthesia per quadrant at surgery end time, use of a throat pack, and orogastric/nasogastric (OG/NG) tube suctioning prior to extubation to minimize ingestion of blood. Pain and anxiety medications prior to and during surgery include 2 mg midazolam, fentanyl per anesthesia, toradol, and dexmedetomidine. Having this protocol will help minimize confounding variables that could affect the primary outcome-- incidence and severity of PONV.
The objectives for this research are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative carbohydrate drink | Experimental | Participants randomized into this group will receive a carbohydrate drink before surgery. |
|
| Preoperative fasting | No Intervention | Participants randomized into this group will be fasting/nothing by mouth (NPO) before surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate drink | Other | The >50 g carbohydrate drink will be consumed up to 2 hours prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of post operative nausea and vomiting (PONV) | The post operative nausea and vomiting (PONV) intensity scale will be used to assess this outcome. It has 3 questions about nausea and vomiting and a question about the duration of nausea. Scores of 50 or greater are considered clinically important. | 6 hours and 24 hours after surgery |
| PONV based on the visual analog scale | A visual analog scale from 0-10 (0= No nausea, 10= Worst possible nausea/vomiting) competed by the participant after surgery. | 6 hours and 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of opioids used for post operative pain | The amount of Oxycodone/Dilaudid will be abstracted from the electronic medical record (EMR) and converted and measured in morphine equivalents (MEQ) | Discharge from hospital usually 1-2 days |
| The aount of anti-emetics used for PONV |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Apfel Score | The simplified Apfel-score Scoring system will be used to assess risk of PONV. Scores can range from 0 to 4 based on these risk factors- Gender. Male= 0. Female=1; Smoking status. Smoker=0, Nonsmoker. =1; History of motion sickness or PONV. No= 0, Yes=1; Use of postoperative opioids. No=0, Yes=1. LoweV. The incidence of PONV, with the presence of 0, 1, 2, 3, and 4 risk factors is approximately 10%, 20%, 40%, 60%, and 80%, respectively. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angeline Nguyen, DMD | Contact | 617-638-4386 | angeline.nguyen@bmc.org | |
| Radhika Chigurupati, DMD MS | Contact | 617-638-4386 | rchiguru@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angeline Nguyen, DMD | Boston Medical Center, Oral and Maxillofacial Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center, Oral and Maxillofacial Surgey | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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The amount of anti-emetics will be abstracted from the EMR |
| Discharge from hospital usually1-2 days |
| Frequency of emesis events | The frequency of emesis will be abstracted from the EMR | Discharge from hospital usually 1-2 days |
| Post-operative fluid intake by mouth/per os (PO) | Post operative po fluids will be assessed in mL, abstracted from the EMR | Discharge from hospital usually 1-2 days |
| Need for intravenous (IV) fluids | The number of participants who needed IV fluids will be abstracted from the EMR | Discharge from hospital usually 1-2 days |
| Length of hospital stay | The length of hospital stay in days will be abstracted from the EMR | Discharge from hospital usually1-2 days |
| 9 months |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |