Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481670
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-24
Brief Title:
Carbohydrate Fluids and Post Operative Nausea and Vomiting
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PONV
Brief 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 patients 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 05 bupivacaine local anesthesia per quadrant at surgery end time use of a throat pack and orogastricnasogastric OGNG 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 patients pre-post-operative anxiety
To compare the amountnumber 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 intakeinability to tolerate PO fluids
To evaluate if patient Apfel score is also a strong indicator for incidenceseverity of PONV
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 05 bupivacaine local anesthesia per quadrant at surgery end time use of a throat pack and orogastricnasogastric OGNG 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 patients pre-post-operative anxiety
To compare the amountnumber 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 intakeinability to tolerate PO fluids
To evaluate if patient Apfel score is also a strong indicator for incidenceseverity of PONV
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None