Carbohydrate Fluids and Post Operative Nausea and Vomiting (PONV)

Boston Medical Center (BMC)

Status

Begins enrollment this month

Conditions

Vomiting, Postoperative

Nausea, Postoperative

Treatments

Other: Carbohydrate drink

Study type

Interventional

Funder types

Other

Identifiers

NCT06481670

H-45096

Details and patient eligibility

About

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

Enrollment

32 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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