Boston Medical Center, Oral and Maxillofacial Surgey
Boston, Massachusetts, 02118, United States
NCT Number: NCT06481670
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
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The >50 g carbohydrate drink will be consumed up to 2 hours prior to surgery.
Other names: Apple juice
Time frame: 6 hours and 24 hours after surgery
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.
Time frame: 6 hours and 24 hours after surgery
A visual analog scale from 0-10 (0= No nausea, 10= Worst possible nausea/vomiting) competed by the participant after surgery.
Time frame: Discharge from hospital usually 1-2 days
The amount of Oxycodone/Dilaudid will be abstracted from the electronic medical record (EMR) and converted and measured in morphine equivalents (MEQ)
Time frame: Discharge from hospital usually1-2 days
The amount of anti-emetics will be abstracted from the EMR
Time frame: Discharge from hospital usually 1-2 days
The frequency of emesis will be abstracted from the EMR
Time frame: Discharge from hospital usually 1-2 days
Post operative po fluids will be assessed in mL, abstracted from the EMR
Time frame: Discharge from hospital usually 1-2 days
The number of participants who needed IV fluids will be abstracted from the EMR
Time frame: Discharge from hospital usually1-2 days
The length of hospital stay in days will be abstracted from the EMR
Time frame: 9 months
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.
Contact information is provided by the study sponsor or research team.
Angeline Nguyen, DMD
CONTACT
Radhika Chigurupati, DMD MS
CONTACT
Boston Medical Center
Other
The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients
Acronym: PONV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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