Carbohydrate Fluids and Post Operative Nausea and Vomiting (PONV)

The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nausea, Postoperative; Vomiting, Postoperative
• Intervention / Treatment: Other: Carbohydrate drink

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angeline Nguyen, DMD; Phone Number: 617-638-4386; Email: angeline.nguyen@bmc.org
• Study Contact Backup: Name: Radhika Chigurupati, DMD MS; Phone Number: 617-638-4386; Email: rchiguru@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center, Oral and Maxillofacial Surgey
      • Contact: Angeline Nguyen, DMD; Email: angeline.nguyen@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative carbohydrate drink; Participants randomized into this group will receive a carbohydrate drink before surgery.	Other: Carbohydrate drink; The >50 g carbohydrate drink will be consumed up to 2 hours prior to surgery.; Other Names: Apple juice
No Intervention: Preoperative fasting; Participants randomized into this group will be fasting/nothing by mouth (NPO) before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Angeline Nguyen, DMD, Boston Medical Center, Oral and Maxillofacial Surgery

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Orthognathic surgery; Enhanced recovery after surgery (ERAS); Carbohydrate rich drinks
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting
• Other Study ID Numbers: H-45096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No