ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 233

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Cohort Comparison Cohort
Hide Arm/Group Description Patients undergoing maxillary surgery using antiemetic anesthesia protocol This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
Period Title: Overall Study
Started 96 137
Completed 93 137
Not Completed 3 0
Reason Not Completed
Protocol Violation             3             0
Arm/Group Title Intervention Cohort Comparison Cohort Total
Hide Arm/Group Description This arm was managed perioperatively with the protocol. This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation. Total of all reporting groups
Overall Number of Baseline Participants 93 137 230
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 93 participants 137 participants 230 participants
20
(17 to 24)
19
(17 to 23)
19
(17 to 23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 137 participants 230 participants
Female
54
  58.1%
89
  65.0%
143
  62.2%
Male
39
  41.9%
48
  35.0%
87
  37.8%
1.Primary Outcome
Title Post-operative Nausea
Hide Description 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.
Time Frame End of surgery to discharge from hospital
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Cohort Comparison Cohort
Hide Arm/Group Description:
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
Overall Number of Participants Analyzed 93 137
Measure Type: Number
Unit of Measure: percentage of subjects with PON
24 70
2.Primary Outcome
Title Post-operative Vomiting
Hide Description [Not Specified]
Time Frame End of surgery to discharge from hospital
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Cohort Comparison Cohort
Hide Arm/Group Description:
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
Overall Number of Participants Analyzed 93 137
Measure Type: Number
Unit of Measure: percentage of subjects with POV
11 28
3.Secondary Outcome
Title Hospital Length of Stay
Hide Description Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.
Time Frame Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Cohort Comparison Cohort
Hide Arm/Group Description:
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
Overall Number of Participants Analyzed 93 137
Median (Inter-Quartile Range)
Unit of Measure: hours
26.4
(23.5 to 32.6)
28.2
(23.5 to 41.4)
4.Secondary Outcome
Title Post-discharge Nausea
Hide Description To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital
Time Frame 1 week from discharge from hospital
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.
Arm/Group Title Intervention Cohort Comparison Cohort
Hide Arm/Group Description:
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary.
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
Overall Number of Participants Analyzed 79 103
Measure Type: Number
Unit of Measure: percentage of subjects with PDN
72 60
5.Secondary Outcome
Title Post-discharge Vomiting
Hide Description [Not Specified]
Time Frame 1 week post discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.
Arm/Group Title Intervention Cohort Comparison Cohort
Hide Arm/Group Description:
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
Overall Number of Participants Analyzed 79 103
Measure Type: Number
Unit of Measure: percentage of subjects with PDV
22 29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Cohort Comparison Cohort
Hide Arm/Group Description Patients undergoing maxillary surgery using the antiemetic anesthesia protocol This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
All-Cause Mortality
Intervention Cohort Comparison Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Cohort Comparison Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/137 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Intervention Cohort Comparison Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/137 (0.00%) 
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
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