Carbohydrate Fluids and Post Operative Nausea and Vomiting

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorBoston Medical Center

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbohydrate drink

    Other intervention

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Preoperative carbohydrate drinkExperimental treatment 1 intervention
Group B: Preoperative fastingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 hours and 24 hours after surgery
2

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.

Time frame
6 hours and 24 hours after surgery

Secondary outcomes

1

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)

Time frame
Discharge from hospital usually 1-2 days
2

The aount of anti-emetics used for PONV

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

Time frame
Discharge from hospital usually1-2 days
3

Frequency of emesis events

The frequency of emesis will be abstracted from the EMR

Time frame
Discharge from hospital usually 1-2 days
4

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

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

Time frame
Discharge from hospital usually 1-2 days

Other outcomes

1

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.

Time frame
9 months

Sponsors and contacts

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