Clinical trial NCT06481670: Carbohydrate Fluids and Post Operative Nausea and Vomiting
Official title: The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nausea, Postoperative
Vomiting, Postoperative
Keywords: Orthognathic surgery
Carbohydrate rich drinks
Enhanced recovery after surgery (ERAS)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: Inclusion Criteria:

* Healthy, American Society of Anesthesiologists (ASA) I-II patients undergoing orthognathic surgery (single jaw, double jaw +/- adjunctive procedures including segmental Le Forts/genioplasty/septoplasty/turbinectomy)
* Operating room (OR) time scheduled prior to 12 pm

Exclusion Criteria:

* Non-English speaking/poor English comprehension
* Patient refusal
* Surgically Assisted Rapid Palatal Expansion (SARPE)
* Orthognathic surgery patients in addition to adjunctive procedures such as temporomandibular joint (TMJ) replacement, fat grafting, liposuction, or septorhinoplasty
* General Anesthesia using total IV anesthesia (TIVA)
* History of gastroesophageal reflux disease (GERD) or patient's with conditions that impair gastrointestinal (GI) motility
* History of motion sickness or postoperative nausea and vomiting (PONV)
* Hx of Diabetes Mellitus, endocrine disorders, or allergy to medications of the study
* Pre-operative scopolamine patch

Primary outcomes:
measure: Intensity of post operative nausea and vomiting (PONV)
timeFrame: 6 hours and 24 hours after surgery
measure: PONV based on the visual analog scale
timeFrame: 6 hours and 24 hours after surgery
Secondary outcomes:
measure: The amount of opioids used for post operative pain
timeFrame: Discharge from hospital usually 1-2 days
measure: The aount of anti-emetics used for PONV
timeFrame: Discharge from hospital usually1-2 days
measure: Frequency of emesis events
timeFrame: Discharge from hospital usually 1-2 days
measure: Post-operative fluid intake by mouth/per os (PO)
timeFrame: Discharge from hospital usually 1-2 days
measure: Need for intravenous (IV) fluids
timeFrame: Discharge from hospital usually 1-2 days
measure: Length of hospital stay
timeFrame: Discharge from hospital usually1-2 days
Other outcomes:
measure: Patient Apfel Score
timeFrame: 9 months
Locations:
city: Boston
country: United States
facility: Boston Medical Center, Oral and Maxillofacial Surgey
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Oral and Maxillofacial Surgery
name: Angeline Nguyen, DMD
role: PRINCIPAL_INVESTIGATOR
References: