Carbohydrate Fluids and Post Operative Nausea and Vomiting

NCT ID: NCT06481670

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Preoperative carbohydrate drink

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

Group Type: EXPERIMENTAL

Carbohydrate drink

Intervention Type: OTHER

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

Preoperative fasting

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Carbohydrate drink

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

Intervention Type: OTHER

Other Intervention Names

Apple juice

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angeline Nguyen, DMD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Oral and Maxillofacial Surgery

Locations

Boston Medical Center, Oral and Maxillofacial Surgey

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Angeline Nguyen, DMD

Role: CONTACT

angeline.nguyen@bmc.org

617-638-4386

Radhika Chigurupati, DMD MS

Role: CONTACT

rchiguru@bu.edu

617-638-4386

Facility Contacts

Angeline Nguyen, DMD

Role: primary

angeline.nguyen@bmc.org

Other Identifiers

H-45096

Identifier Type: -

Identifier Source: org_study_id