Carbohydrate Fluids and Post Operative Nausea and Vomiting
NCT Number: NCT06481670
Acronym: PONV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nausea, Postoperative|Vomiting, Postoperative
Interventions: OTHER: Carbohydrate drink
Sponsor: Boston Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-11
Completion Date: 2025-11
Locations: Boston Medical Center, Oral and Maxillofacial Surgey, Boston, Massachusetts, 02118, United States

Summary:
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:

* To evaluate if pre-operative clear CHO help reduce incidence and intensity of PONV.
* To assess if pre-operative clear carbohydrate fluids affect length of hospital stay
* To determine if pre-operative CHO reduce patient's pre-/post-operative anxiety
* To compare the amount/number of opioids and anti-emetics needed post-operatively between the two groups
* To compare ability for patients to return to PO hydration via the amount of fluid ingestion (mL) vs. if they need IV fluids due to decreased PO intake/inability to tolerate PO fluids
* To evaluate if patient Apfel score is also a strong indicator for incidence/severity of PONV

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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
Other Outcome Measures: 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., 9 months