Nausea, PostoperativePONVNCT06481670
Carbohydrate Fluids and Post Operative Nausea and Vomiting
A study testing Carbohydrate drink in people with Nausea, Postoperative and Vomiting, Postoperative, run by Boston Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nausea, Postoperative, Vomiting, Postoperative
- What is being tested?
- Carbohydrate drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients
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.
Read more
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
- Being tested
- Carbohydrate drink
- Keywords
- Orthognathic surgery, Carbohydrate rich drinks, Enhanced recovery after surgery (ERAS)
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkOther
Also called Apple juice
The >50 g carbohydrate drink will be consumed up to 2 hours prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative carbohydrate drink | Experimental | Participants randomized into this group will receive a carbohydrate drink before surgery. Receives: Other: Carbohydrate drink |
| Preoperative fasting | No intervention | Participants randomized into this group will be fasting/nothing by mouth (NPO) before surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 hours and 24 hours after surgery
Secondary outcomes (6)
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)
Measured: Discharge from hospital usually 1-2 days
The aount of anti-emetics used for PONV
The amount of anti-emetics will be abstracted from the EMR
Measured: Discharge from hospital usually1-2 days
Frequency of emesis events
The frequency of emesis will be abstracted from the EMR
Measured: Discharge from hospital usually 1-2 days
Post-operative fluid intake by mouth/per os (PO)
Post operative po fluids will be assessed in mL, abstracted from the EMR
Measured: Discharge from hospital usually 1-2 days
Need for intravenous (IV) fluids
The number of participants who needed IV fluids will be abstracted from the EMR
Measured: Discharge from hospital usually 1-2 days
Length of hospital stay
The length of hospital stay in days will be abstracted from the EMR
Measured: Discharge from hospital usually1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start2 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: IRB review was not completed and study was not done.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angeline Nguyen, DMD, Principal investigator, Boston Medical Center, Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481670
- Sponsor's protocol ID
- H-45096
- Acronym
- PONV
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients
- ClinicalTrials.gov ID
- NCT06481670
- Acronym / sponsor ID
- PONV / H-45096
- Conditions
- Nausea, Postoperative, Vomiting, Postoperative
- Keywords
- Orthognathic surgery, Carbohydrate rich drinks, Enhanced recovery after surgery (ERAS)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB review was not completed and study was not done.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative carbohydrate drink | Experimental | Other: Carbohydrate drinkParticipants randomized into this group will receive a carbohydrate drink before surgery. |
| Preoperative fasting | No intervention | –Participants randomized into this group will be fasting/nothing by mouth (NPO) before surgery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate drinkAlso: Apple juiceThe >50 g carbohydrate drink will be consumed up to 2 hours prior to surgery. | Other | Preoperative carbohydrate drink |
Primary outcome
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.
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.
6 secondary outcomes
The amount of opioids used for post operative pain
Time frame: Discharge from hospital usually 1-2 days
The aount of anti-emetics used for PONV
Time frame: Discharge from hospital usually1-2 days
Frequency of emesis events
Time frame: Discharge from hospital usually 1-2 days
Post-operative fluid intake by mouth/per os (PO)
Time frame: Discharge from hospital usually 1-2 days
Need for intravenous (IV) fluids
Time frame: Discharge from hospital usually 1-2 days
Length of hospital stay
Time frame: Discharge from hospital usually1-2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeline Nguyen, DMD principal investigator
Boston Medical Center, Oral and Maxillofacial Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate drink in people with Nausea, Postoperative and Vomiting, Postoperative, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of post operative nausea and vomiting (PONV) (time frame: 6 hours and 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.