Carbohydrate Fluids for Postoperative Nausea and Vomiting

(PONV Trial)

Overseen By Radhika Chigurupati, DMD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must not be taking: Scopolamine

Disqualifiers: Non-English, GERD, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of gastroesophageal reflux disease, motion sickness, or diabetes, you may not be eligible to participate.

What data supports the effectiveness of the treatment carbohydrate drink for reducing postoperative nausea and vomiting?

Research suggests that a carbohydrate drink given before surgery may help reduce nausea and vomiting after surgery by improving the body's metabolic state during the operation. ^{1 2 3 4 5}

Is it safe to use carbohydrate fluids for postoperative nausea and vomiting?

Research shows that carbohydrate drinks are generally safe for use in humans, as they are used to improve comfort and reduce nausea and vomiting after surgery. No significant safety concerns have been reported in the studies reviewed. ^{1 3 4 5 6}

How does the carbohydrate drink treatment differ from other treatments for postoperative nausea and vomiting?

The carbohydrate drink is unique because it is given before surgery to improve the body's metabolic state, which may help reduce nausea and vomiting after surgery. Unlike other treatments that are often given after symptoms appear, this drink is used proactively to potentially prevent these symptoms. ^{1 3 4 5 6}

Research Team

Angeline Nguyen, DMD

Principal Investigator

Boston Medical Center, Oral and Maxillofacial Surgery

Eligibility Criteria

This trial is for patients undergoing oral and maxillofacial surgery at Boston Medical Center who can safely consume a carbohydrate drink before their operation. It's not specified who cannot join, but typically those with allergies to the study materials or conflicting medical conditions would be excluded.

Inclusion Criteria

I am healthy and have a low to moderate risk for complications during surgery.

Operating room (OR) time scheduled prior to 12 pm

Exclusion Criteria

I will use a scopolamine patch before surgery.

I am having jaw surgery and may also have surgery on my jaw joint, fat grafting, liposuction, or nose reshaping.

Non-English speaking/poor English comprehension

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive pre-operative carbohydrate fluids or undergo fasting before surgery

1 day

1 visit (in-person)

Surgery and Immediate Post-operative

Participants undergo surgery with the ERAS protocol and are monitored for PONV intensity and incidence

6-24 hours

In-patient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PONV assessment and hospital discharge

1-2 days

Treatment Details

Interventions

• Carbohydrate drink

Trial Overview The study tests if drinking more than 50 grams of carbohydrates (like apple juice) before surgery can reduce nausea and vomiting after the operation. Patients will follow an Enhanced Recovery After Surgery protocol to limit other factors that could affect results.

Participant Groups

Group I: Preoperative carbohydrate drink Experimental Treatment 1 Intervention

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

Group II: Preoperative fasting Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a Preoperative Carbohydrate Load on Postoperative Recovery in Children: A Randomised, Double-Blind, Placebo-Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Preoperative Nutrition and Postoperative Discomfort in an ERAS Setting: A Randomized Study in Gastric Bypass Surgery. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of the effects of oral preoperative carbohydrates on postoperative nausea and vomiting after laparoscopic cholecystectomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effects on gastric emptying and carbohydrate loading of an oral nutritional supplement and an oral rehydration solution: a crossover study with magnetic resonance imaging. [2014]

5. Thailand pubmed.ncbi.nlm.nih.gov

Oral rehydration with 10% carbohydrate drink for preventing postoperative nausea and vomiting (PONV) after low dose of spinal morphine. [2014]

6. India pubmed.ncbi.nlm.nih.gov

Preoperative oral carbohydrate loading: Effects on intraoperative blood glucose levels, post-operative nausea and vomiting, and intensive care unit stay. [2022]