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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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Post-operative Nausea
Post-operative Vomiting
Nausea Persistent
Intervention: Other: Antiemetic anesthesia protocol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Cohort Patients undergoing maxillary surgery using antiemetic anesthesia protocol
Comparison Cohort This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.

Participant Flow:   Overall Study
    Intervention Cohort   Comparison Cohort
STARTED   96   137 
COMPLETED   93   137 
NOT COMPLETED   3   0 
Protocol Violation                3                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intervention Cohort This arm was managed perioperatively with the protocol.
Comparison Cohort This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
Total Total of all reporting groups

Baseline Measures
   Intervention Cohort   Comparison Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   137   230 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 20 
 (17 to 24) 
 19 
 (17 to 23) 
 19 
 (17 to 23) 
Gender 
[Units: Participants]
     
Female   54   89   143 
Male   39   48   87 


  Outcome Measures

1.  Primary:   Post-operative Nausea   [ Time Frame: End of surgery to discharge from hospital ]

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

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

4.  Secondary:   Post-discharge Nausea   [ Time Frame: 1 week from discharge from hospital ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jay Anderson, PI
Organization: UNC Chapel Hill
phone: 919-966-5136
e-mail: janderson@aims.unc.edu


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 Submitted: April 16, 2012
First Posted: May 7, 2012
Results First Submitted: July 14, 2014
Results First Posted: August 6, 2014
Last Update Posted: August 20, 2014