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Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery

This study is currently recruiting participants.
Verified March 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01592708
First received: April 16, 2012
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Post-operative Nausea
Post-operative Vomiting
Post-discharge Nausea
Post-discharge Vomiting
 Other: Anesthesia and postoperative medication and fluid protocol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Post-operative nausea and vomiting [ Time Frame: End of surgery to discharge from hospital - average 3 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Hospital length of stay [ Time Frame: Anesthesia start time to placement of discharge order - average 3 days ] [ Designated as safety issue: No ]
    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 and vomiting [ Time Frame: 1 week from discharge from hospital ] [ Designated as safety issue: No ]
    To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Anesthesia and postoperative medication and fluid protocol
    Scopolamine 1.5 milligram(mg) patch for 48 hours(h), Midazolam 1-2mg intravenous(IV) once, Propofol & remifentanil IV for general anesthesia, Neostigmine maximum 2.5mg, 250mg erythromycin by mouth(po) every(q)8h for 2 doses, Solumedrol and Depomedrol dosing per surgeon, 0.625mg IV droperidol and 4mg IV/8mg sublingual(SL) Zofran at end of surgery, nasogastric tube used to empty stomach at end of case then removed, Ketorolac 30mg IV at start of surgery then 15mg IV q6h for 24h. Then ibuprofen 600mg po q6h as needed for pain. Breakthrough pain: Fentanyl IV in recovery room, Hydromorphone IV after leaving recovery room, Hydrocodone/tylenol po. May substitute other opioids if no response. For nausea/vomiting in recovery room: Promethazine 6.25-25mg IV or per rectum(PR); Decadron 4mg IV; or Benadryl 25-50mg IV/po. IV fluids: Total at least 25 milliliters per kilogram (mL/kg)-10mL/kg in OR. For nausea/vomiting after recovery room: 4mg IV or 8mg SL zofran q6h or 6.25-25mg phenergan (IV or PR)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592708

Contacts
Contact: Jay Anderson, DDS, MD janderson@aims.unc.edu
Contact: Carolyn Brookes, DMD, MD cdicus@unch.unc.edu

Locations
United States, North Carolina
UNC-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Jay Anderson, DDS,MD     919-923-0544     jay_anderson@dentistry.unc.edu    
UNC-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Jay Anderson, DDS, MD     919-923-0544     jay_anderson@dentistry.unc.edu    
Principal Investigator: Jay Anderson, DDS, MD            
Sub-Investigator: Vincent Kopp, MD            
Sub-Investigator: Turvey Timothy, DDS            
Sub-Investigator: Golden Brent, DMD, MD            
Sub-Investigator: John Berry, MD            
Sub-Investigator: Carolyn Brookes, DMD, MD            
Sub-Investigator: Ceib Phillips, PhD            
Sub-Investigator: George Blakey, DMD            
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
  More Information

Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01592708     History of Changes
Other Study ID Numbers: 12-0622, R01DE005215
Study First Received: April 16, 2012
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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
Postoperative Nausea and Vomiting
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013