Trial Outcomes & Findings for Pharmacogenomics and Post-Operative Nausea and Vomiting (NCT NCT03503292)
NCT ID: NCT03503292
Last Updated: 2020-10-28
Results Overview
The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
0-48 hours post bariatric surgery
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
CYP2D6 Rapid Metabolizer (Granisetron)
Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Granisetron: Rapid metabolizer received 1mg IV Granisetron
|
CYP2D6 Normal Metabolizer (Ondansetron)
Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
90
|
|
Overall Study
COMPLETED
|
2
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenomics and Post-Operative Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
CYP2D6 Rapid Metabolizer (Granisetron)
n=2 Participants
Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Granisetron: Rapid metabolizer received 1mg IV Granisetron
|
CYP2D6 Normal Metabolizer (Ondansetron)
n=90 Participants
Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 21.2 • n=99 Participants
|
47.1 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
47.2 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
90 participants
n=107 Participants
|
92 participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
46.6 kg/m2
STANDARD_DEVIATION 15.9 • n=99 Participants
|
45.4 kg/m2
STANDARD_DEVIATION 9.0 • n=107 Participants
|
45.4 kg/m2
STANDARD_DEVIATION 9.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 0-48 hours post bariatric surgeryThe total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.
Outcome measures
| Measure |
CYP2D6 Rapid Metabolizer (Granisetron)
n=2 Participants
Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Granisetron: Rapid metabolizer received 1mg IV Granisetron
|
CYP2D6 Normal Metabolizer (Ondansetron)
n=90 Participants
Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
|
|---|---|---|
|
Episodes of Postoperative Nausea
|
0 episodes
|
16 episodes
|
PRIMARY outcome
Timeframe: 0-48 hours post bariatric surgeryThe total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication.
Outcome measures
| Measure |
CYP2D6 Rapid Metabolizer (Granisetron)
n=2 Participants
Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Granisetron: Rapid metabolizer received 1mg IV Granisetron
|
CYP2D6 Normal Metabolizer (Ondansetron)
n=90 Participants
Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
|
|---|---|---|
|
Episodes of Postoperative Vomiting
|
0 episodes
|
4 episodes
|
Adverse Events
CYP2D6 Rapid Metabolizer (Granisetron)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CYP2D6 Normal Metabolizer (Ondansetron)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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