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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
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Post-operative Nausea Post-operative Vomiting Nausea Persistent Other: Antiemetic anesthesia protocol Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Other Names:
  • 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



Primary Outcome Measures :
  1. 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.

  2. Post-operative Vomiting [ Time Frame: End of surgery to discharge from hospital ]

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Post-discharge Vomiting [ Time Frame: 1 week post discharge ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
United States, North Carolina
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Study Chair: Ceib Philllips, PhD, MPH University of North Carolina, Chapel Hill

Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01592708     History of Changes
Other Study ID Numbers: 12-0622
R01DE005215 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2012    Key Record Dates
Results First Posted: August 6, 2014
Last Update Posted: August 20, 2014
Last Verified: June 2014

Keywords provided by University of North Carolina, Chapel Hill:
orthognathic surgery
maxillary osteotomy
post operative nausea vomiting
post discharge nausea vomiting
anesthesia

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Propofol
Fentanyl
Remifentanil
Ondansetron
Hydrocodone
Droperidol
Scopolamine Hydrobromide
Ibuprofen
Ketorolac
Acetaminophen
Butylscopolammonium Bromide
Methylprednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Antiemetics
Erythromycin stearate
Prednisolone hemisuccinate