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Carbohydrate Fluids and Post Operative Nausea and Vomiting

Study acronym: PONV
StatusWithdrawn
PhaseNot applicable
Started
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Record History

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  1. Stopped Withdrawn before enrolling Sponsor's reason: IRB review was not completed and study was not done. Show 5 more changesShow less
    • Enrollment target: estimated 32 to confirmed 0
    • Study sites: 1 to 0
    • Start date changed from estimate of Sep 2026 to Jun 2, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Notable Start date: Jun 2026 to Sep 2026
    • Primary and study completion pushed from Dec 2026 to Mar 2027
    v9
  3. Notable Start date: Apr 2026 to Jun 2026
    • Primary and study completion pushed from Sep 2026 to Dec 2026
    v8
  4. Notable Start date: Feb 2026 to Apr 2026
    • Primary and study completion dates: Jul 2026 to Sep 2026
    v7
  5. Notable Start date: Nov 2025 to Feb 2026
    • Primary and study completion dates: Mar 2026 to Jul 2026
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Sep 2025 to Nov 2025
    • Primary and study completion dates: Dec 2025 to Mar 2026
    v5
  2. Notable Start date: Jun 2025 to Sep 2025
    • Primary and study completion dates: Sep 2025 to Dec 2025
    v4
  3. Notable Primary completion date: Feb 2025 to Sep 2025
    • Start date: Nov 2024 to Jun 2025
    • Study completion date: Nov 2025 to Sep 2025
    v3
  4. Notable Start date: Aug 2024 to Nov 2024
    • Primary completion date: Sep 2025 to Feb 2025
    • Study completion date: Sep 2025 to Nov 2025
    • Secondary endpoints revised (6)
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06481670
Lead Sponsor Boston Medical Center
Conditions
(from sponsor)
Nausea, Postoperative, Vomiting, Postoperative
Related terms Postoperative Nausea and Vomiting
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov