[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553098":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":55,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":81,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Boston Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Preoperative carbohydrate drink","EXPERIMENTAL","Participants randomized into this group will receive a carbohydrate drink before surgery.",[13],"Other: Carbohydrate drink",{"label":15,"type":16,"description":17,"interventionNames":18},"Preoperative fasting","NO_INTERVENTION","Participants randomized into this group will be fasting\u002Fnothing by mouth (NPO) before surgery.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Carbohydrate drink","The \\>50 g carbohydrate drink will be consumed up to 2 hours prior to surgery.",[9],[25],"Apple juice",[27],{"name":28,"affiliation":29,"role":30},"Angeline Nguyen, DMD","Boston Medical Center, Oral and Maxillofacial Surgery","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","617-638-4386","angeline.nguyen@bmc.org",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},"Radhika Chigurupati, DMD MS","rchiguru@bu.edu",[40],{"facility":41,"status":18,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Boston Medical Center, Oral and Maxillofacial Surgey","Boston","Massachusetts","02118","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.05977,42.35843,{"lat":51,"lon":50},[54],{"name":28,"role":33,"phone":18,"phoneExt":18,"email":35},{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100553098","carbohydrate-fluids-and-post-operative-nausea-and-vomiting-100553098",false,"NCT06481670","Carbohydrate Fluids and Post Operative Nausea and Vomiting","The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients","PONV","Inclusion Criteria:\n\n* Healthy, American Society of Anesthesiologists (ASA) I-II patients undergoing orthognathic surgery (single jaw, double jaw +\u002F- adjunctive procedures including segmental Le Forts\u002Fgenioplasty\u002Fseptoplasty\u002Fturbinectomy)\n* Operating room (OR) time scheduled prior to 12 pm\n\nExclusion Criteria:\n\n* Non-English speaking\u002Fpoor English comprehension\n* Patient refusal\n* Surgically Assisted Rapid Palatal Expansion (SARPE)\n* Orthognathic surgery patients in addition to adjunctive procedures such as temporomandibular joint (TMJ) replacement, fat grafting, liposuction, or septorhinoplasty\n* General Anesthesia using total IV anesthesia (TIVA)\n* History of gastroesophageal reflux disease (GERD) or patient's with conditions that impair gastrointestinal (GI) motility\n* History of motion sickness or postoperative nausea and vomiting (PONV)\n* Hx of Diabetes Mellitus, endocrine disorders, or allergy to medications of the study\n* Pre-operative scopolamine patch","ALL","19 Years",{"count":68,"type":69},32,"ESTIMATED","INTERVENTIONAL",[72],"NA","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).\n\nDuring 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\u002Fnasogastric (OG\u002FNG) 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.\n\nThe objectives for this research are:\n\n* To evaluate if pre-operative clear CHO help reduce incidence and intensity of PONV.\n* To assess if pre-operative clear carbohydrate fluids affect length of hospital stay\n* To determine if pre-operative CHO reduce patient's pre-\u002Fpost-operative anxiety\n* To compare the amount\u002Fnumber of opioids and anti-emetics needed post-operatively between the two groups\n* 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\u002Finability to tolerate PO fluids\n* To evaluate if patient Apfel score is also a strong indicator for incidence\u002Fseverity of PONV",[75,76],"Nausea, Postoperative","Vomiting, Postoperative",[78,79,80],"Orthognathic surgery","Carbohydrate rich drinks","Enhanced recovery after surgery (ERAS)","NOT_YET_RECRUITING","2026-06-29",{"date":84,"type":85},"2026-06-30","ACTUAL",{"date":87,"type":69},"2026-09",{"date":89,"type":69},"2027-03",{"name":5,"class":6},1]