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

Overview

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

Interventions

• Other Carbohydrate drink
  The \>50 g carbohydrate drink will be consumed up to 2 hours prior to surgery.

Primary outcome measures

• Intensity of post operative nausea and vomiting (PONV) [Time frame: 6 hours and 24 hours after surgery]
• PONV based on the visual analog scale [Time frame: 6 hours and 24 hours after surgery]

Secondary outcome measures (6)

• The amount of opioids used for post operative pain [Time frame: Discharge from hospital usually 1-2 days]
• The aount of anti-emetics used for PONV [Time frame: Discharge from hospital usually1-2 days]
• Frequency of emesis events [Time frame: Discharge from hospital usually 1-2 days]
• Post-operative fluid intake by mouth/per os (PO) [Time frame: Discharge from hospital usually 1-2 days]
• Need for intravenous (IV) fluids [Time frame: Discharge from hospital usually 1-2 days]
• Length of hospital stay [Time frame: Discharge from hospital usually1-2 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Boston Medical Center, Oral and Maxillofacial Surgey — Boston

Identifiers

NCT: NCT06481670 · H-45096

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗