N/A
N=233
Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery
Post-operative Nausea · Post-operative Vomiting · Nausea Persistent
Bottom Line
View on ClinicalTrials.gov: NCT01592708 ↗Enrolled (actual)
233
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Post-operative Nausea — 24; 70 percentage of subjects with PON
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Antiemetic anesthesia protocol (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Nausea |
24; 70 | — |
| PRIMARY Post-operative Vomiting |
11; 28 | — |
| SECONDARY Hospital Length of Stay |
26.4; 28.2 | — |
| SECONDARY Post-discharge Nausea |
72; 60 | — |
| SECONDARY Post-discharge Vomiting |
22; 29 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01592708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.