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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01592708
First received: April 16, 2012
Last updated: August 15, 2014
Last verified: June 2014
  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
Nausea Persistent
Other: Antiemetic anesthesia 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:


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

Primary Outcome Measures:
  • Post-operative Nausea [ Time Frame: End of surgery to discharge from hospital ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours ] [ 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 [ 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

  • Post-discharge Vomiting [ Time Frame: 1 week post discharge ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: June 2012
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Results First Received: July 14, 2014
Last Updated: August 15, 2014
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
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics
Antiemetics
Erythromycin
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anti-Bacterial Agents
Anti-Infective Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014