Trial Outcomes & Findings for Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery (NCT NCT01592708)
NCT ID: NCT01592708
Last Updated: 2014-08-20
Results Overview
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.
COMPLETED
NA
233 participants
End of surgery to discharge from hospital
2014-08-20
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
137
|
|
Overall Study
COMPLETED
|
93
|
137
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
Baseline Characteristics
Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery
Baseline characteristics by cohort
| Measure |
Intervention Cohort
n=93 Participants
This arm was managed perioperatively with the protocol.
|
Comparison Cohort
n=137 Participants
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20 years
n=5 Participants
|
19 years
n=7 Participants
|
19 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of surgery to discharge from hospitalEnd 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.
Outcome measures
| Measure |
Intervention Cohort
n=93 Participants
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
|
Comparison Cohort
n=137 Participants
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
|
|---|---|---|
|
Post-operative Nausea
|
24 percentage of subjects with PON
|
70 percentage of subjects with PON
|
PRIMARY outcome
Timeframe: End of surgery to discharge from hospitalOutcome measures
| Measure |
Intervention Cohort
n=93 Participants
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
|
Comparison Cohort
n=137 Participants
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
|
|---|---|---|
|
Post-operative Vomiting
|
11 percentage of subjects with POV
|
28 percentage of subjects with POV
|
SECONDARY outcome
Timeframe: Anesthesia start time to placement of hospital discharge order - average 26 - 28 hoursAnesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.
Outcome measures
| Measure |
Intervention Cohort
n=93 Participants
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
|
Comparison Cohort
n=137 Participants
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
|
|---|---|---|
|
Hospital Length of Stay
|
26.4 hours
Interval 23.5 to 32.6
|
28.2 hours
Interval 23.5 to 41.4
|
SECONDARY outcome
Timeframe: 1 week from discharge from hospitalPopulation: This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.
To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital
Outcome measures
| Measure |
Intervention Cohort
n=79 Participants
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
|
Comparison Cohort
n=103 Participants
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
|
|---|---|---|
|
Post-discharge Nausea
|
72 percentage of subjects with PDN
|
60 percentage of subjects with PDN
|
SECONDARY outcome
Timeframe: 1 week post dischargePopulation: This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.
Outcome measures
| Measure |
Intervention Cohort
n=79 Participants
Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
|
Comparison Cohort
n=103 Participants
This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
|
|---|---|---|
|
Post-discharge Vomiting
|
22 percentage of subjects with PDV
|
29 percentage of subjects with PDV
|
Adverse Events
Intervention Cohort
Comparison Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place