Carbohydrate Fluids and Post Operative Nausea and Vomiting

NCT06481670 | Not Yet Recruiting

• 1 other identifier: H-45096
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Nausea, Postoperative; Vomiting, Postoperative

Keywords

Orthognathic surgery; Carbohydrate rich drinks; Enhanced recovery after surgery (ERAS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• The amount of opioids used for post operative pain

  Discharge from hospital usually 1-2 days

• The aount of anti-emetics used for PONV

  Discharge from hospital usually1-2 days

• Frequency of emesis events

  Discharge from hospital usually 1-2 days

• Post-operative fluid intake by mouth/per os (PO)

  Discharge from hospital usually 1-2 days

• Need for intravenous (IV) fluids

  Discharge from hospital usually 1-2 days

Other Outcomes (1)

• Patient Apfel Score

  9 months

Study Arms (2)

Preoperative carbohydrate drink

EXPERIMENTAL

Participants randomized into this group will receive a carbohydrate drink before surgery.

Other: Carbohydrate drink

Preoperative fasting

NO INTERVENTION

Participants randomized into this group will be fasting/nothing by mouth (NPO) before surgery.

Interventions

Carbohydrate drink OTHER

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

Also known as: Apple juice

Preoperative carbohydrate drink

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center, Oral and Maxillofacial Surgey

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Angeline Nguyen, DMD

  Boston Medical Center, Oral and Maxillofacial Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angeline Nguyen, DMD

CONTACT

617-638-4386; angeline.nguyen@bmc.org

Radhika Chigurupati, DMD MS

CONTACT

617-638-4386; rchiguru@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 1, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)