Post-operative Nausea | Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery
Post-operative Nausea research study
What is the primary objective of this study?
The purpose of this study is to determine whether a multi-modal anesthesia and pain control protocol reduces post-operative and post-discharge nausea and vomiting (PONV and PDNV) in patients undergoing upper jaw corrective surgery.
Who is eligible to participate?
Inclusion Criteria: - 15 years old or older - Undergoing elective orthognathic surgery involving a maxillary osteotomy Exclusion Criteria: - uncontrolled GERD or hiatal hernia - glaucoma - seizure disorder - COPD - obstructive sleep apnea - chronic kidney disease stage III or greater - known prolonged QT interval (QTc > 460) or the same found incidentally - history of severe constipation - pre-existing chronic nausea or vomiting - allergies or contraindications to protocol medications - patient insistence on inhalational induction of anesthesia.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Antiemetic anesthesia protocolIntervention 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Antiemetic anesthesia protocolScopolamine 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
Start Date: June 2012
Completed Date: April 2014
Primary Outcome: Post-operative Nausea
Secondary Outcome: Hospital Length of Stay
Study sponsors, principal investigator, and references
Principal Investigator: Ceib Philllips, PhD, MPH
Lead Sponsor: University of North Carolina, Chapel Hill
Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006 Sep;64(9):1385-97. Review.