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NCT Number: NCT06481670

Carbohydrate Fluids and Post Operative Nausea and Vomiting

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Oral and Maxillofacial Surgey

Boston, Massachusetts, 02118, United States

Location contact

Angeline Nguyen, DMD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate Drink

Other

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

Other names: Apple juice

Primary outcomes

  1. Intensity of post operative nausea and vomiting (PONV)

    Time frame: 6 hours and 24 hours after surgery

    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.

  2. PONV based on the visual analog scale

    Time frame: 6 hours and 24 hours after surgery

    A visual analog scale from 0-10 (0= No nausea, 10= Worst possible nausea/vomiting) competed by the participant after surgery.

Secondary outcomes

  1. The amount of opioids used for post operative pain

    Time frame: Discharge from hospital usually 1-2 days

    The amount of Oxycodone/Dilaudid will be abstracted from the electronic medical record (EMR) and converted and measured in morphine equivalents (MEQ)

  2. The aount of anti-emetics used for PONV

    Time frame: Discharge from hospital usually1-2 days

    The amount of anti-emetics will be abstracted from the EMR

  3. Frequency of emesis events

    Time frame: Discharge from hospital usually 1-2 days

    The frequency of emesis will be abstracted from the EMR

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

    Time frame: Discharge from hospital usually 1-2 days

    Post operative po fluids will be assessed in mL, abstracted from the EMR

  5. Need for intravenous (IV) fluids

    Time frame: Discharge from hospital usually 1-2 days

    The number of participants who needed IV fluids will be abstracted from the EMR

  6. Length of hospital stay

    Time frame: Discharge from hospital usually1-2 days

    The length of hospital stay in days will be abstracted from the EMR

Other outcomes

  1. Patient Apfel Score

    Time frame: 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angeline Nguyen, DMD

CONTACT

[email protected]

617-638-4386

Radhika Chigurupati, DMD MS

CONTACT

[email protected]

617-638-4386

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Acronym: PONV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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