Trial Outcomes & Findings for Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting (NCT NCT03297021)
NCT ID: NCT03297021
Last Updated: 2020-07-20
Results Overview
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
141 participants
Primary outcome timeframe
average of 4 hours in PACU and POD1
Results posted on
2020-07-20
Participant Flow
165 patients assessed for eligibility 141 patients were randomized
Participant milestones
| Measure |
Ondansetron 4mg Pre-emergence
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
46
|
47
|
|
Overall Study
COMPLETED
|
43
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
4
|
Reasons for withdrawal
| Measure |
Ondansetron 4mg Pre-emergence
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
|---|---|---|---|
|
Overall Study
Incomplete/illegible data sheet
|
4
|
2
|
3
|
|
Overall Study
Missing Post-Op Data
|
1
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ondansetron 4mg Pre-emergence
n=43 Participants
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
n=42 Participants
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
n=43 Participants
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40 years
n=43 Participants
|
39 years
n=42 Participants
|
48 years
n=43 Participants
|
40 years
n=128 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=43 Participants
|
36 Participants
n=42 Participants
|
37 Participants
n=43 Participants
|
114 Participants
n=128 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=43 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=43 Participants
|
14 Participants
n=128 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ASA Class
|
1 units on a scale
n=43 Participants
|
1 units on a scale
n=42 Participants
|
1 units on a scale
n=43 Participants
|
1 units on a scale
n=128 Participants
|
|
BMI
|
24.0 kg/m^2
n=43 Participants
|
25.0 kg/m^2
n=42 Participants
|
24.0 kg/m^2
n=43 Participants
|
24 kg/m^2
n=128 Participants
|
|
History of PONV
|
12 Participants
n=43 Participants
|
8 Participants
n=42 Participants
|
13 Participants
n=43 Participants
|
33 Participants
n=128 Participants
|
|
History of Vertigo
|
1 Participants
n=43 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=43 Participants
|
4 Participants
n=128 Participants
|
|
History of Motion Sickness
|
13 Participants
n=43 Participants
|
10 Participants
n=42 Participants
|
17 Participants
n=43 Participants
|
40 Participants
n=128 Participants
|
|
Current Smoker
|
3 Participants
n=43 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=43 Participants
|
9 Participants
n=128 Participants
|
PRIMARY outcome
Timeframe: average of 4 hours in PACU and POD1Population: only those participants with nausea completed the nausea scale
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
Outcome measures
| Measure |
Ondansetron 4mg Pre-emergence
n=10 Participants
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
n=7 Participants
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
n=8 Participants
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
|---|---|---|---|
|
Nausea Scale
POD1
|
2.0 score on a scale
Interval 1.0 to 3.0
|
1.0 score on a scale
Interval 1.0 to 5.5
|
8.0 score on a scale
Interval 8.0 to 8.0
|
|
Nausea Scale
PACU
|
3.5 score on a scale
Interval 1.75 to 4.0
|
4.0 score on a scale
Interval 3.0 to 6.0
|
4.0 score on a scale
Interval 1.5 to 6.0
|
SECONDARY outcome
Timeframe: average of 4 hoursNumber of participants with episodes of vomiting in the Post Anesthesia Care Unit
Outcome measures
| Measure |
Ondansetron 4mg Pre-emergence
n=43 Participants
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
n=42 Participants
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
n=43 Participants
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
|---|---|---|---|
|
Number of Participants With Episodes of Vomiting in the PACU
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
Outcome measures
| Measure |
Ondansetron 4mg Pre-emergence
n=43 Participants
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
n=42 Participants
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
n=43 Participants
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
|---|---|---|---|
|
Number of Participants With Symptoms on POD 1
Headache
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Symptoms on POD 1
Nausea
|
9 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Symptoms on POD 1
Vomiting
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: average of 4 hoursNumber participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU
Outcome measures
| Measure |
Ondansetron 4mg Pre-emergence
n=43 Participants
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
n=42 Participants
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
n=43 Participants
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
|---|---|---|---|
|
Number of Participants Who Needed Rescue Anti-emetics
|
4 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: intraoperative, up to 3.5 hoursOutcome measures
| Measure |
Ondansetron 4mg Pre-emergence
n=43 Participants
Ondansetron 4 MG Pre-emergence
|
Ondansetron 8mg Pre-emergence
n=42 Participants
Ondansetron 8mg Pre-emergence
|
Ondansetron Pre-Incision and Pre-emergence
n=43 Participants
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
|
|---|---|---|---|
|
Total Anesthesia Time
|
116.0 minutes
Interval 93.0 to 178.0
|
128.5 minutes
Interval 86.5 to 186.25
|
118.0 minutes
Interval 93.0 to 172.0
|
Adverse Events
Ondansetron 4mg Pre-emergence
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ondansetron 8mg Pre-emergence
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ondansetron Pre-Incision and Pre-emergence
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
Dr. Daniel Katz
Icahn School of Medicine at Mount Sinai
Phone: 212-241-7475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place