Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery
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|ClinicalTrials.gov Identifier: NCT01592708|
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : August 6, 2014
Last Update Posted : August 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Nausea Post-operative Vomiting Nausea Persistent||Other: Antiemetic anesthesia protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||233 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Evaluation of an Anesthesia Protocol to Reduce Post-operative and Post-discharge Nausea and Vomiting in a High Risk Orthognathic Surgery Population|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: Antiemetic anesthesia protocol
Scopolamine 1.5 milligram(mg) patch Propofol infusion remifentanil infusion 250mg erythromycin po for 2 doses Solumedrol 0.625mg IV droperidol 4mg IV Ondansetron Ketorolac 30mg IV ibuprofen 600mg po q6h Fentanyl Hydrocodone/Tylenol po
Other: Antiemetic anesthesia protocol
Intervention group consisted of patients undergoing maxillary osteotomy who received an antiemetic protocol designed to provide multimodal antiemetic therapy which have been shown to help prevent and/or treat postoperative nausea, combined with the elimination of anesthetic factors that may contribute to postoperative nausea and vomiting.
- Post-operative Nausea [ Time Frame: End of surgery to discharge from hospital ]End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.
- Post-operative Vomiting [ Time Frame: End of surgery to discharge from hospital ]
- Hospital Length of Stay [ Time Frame: Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours ]Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.
- Post-discharge Nausea [ Time Frame: 1 week from discharge from hospital ]To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital
- Post-discharge Vomiting [ Time Frame: 1 week post discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592708
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|Study Chair:||Ceib Philllips, PhD, MPH||University of North Carolina, Chapel Hill|