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Trial Outcomes & Findings for Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery (NCT NCT00659945)

NCT ID: NCT00659945

Last Updated: 2013-02-06

Results Overview

Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS\>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

48 hours post surgery

Results posted on

2013-02-06

Participant Flow

Prospective, double blinded, randomized, two arm evaluation of 150 subjects at high risk for PONV undergoing a standardized general anesthetic with ondansetron and either aprepitant or a placebo. Recruitment period was from June 2008 through November 2009 in the preoperative holding area prior to surgery.

Men and women between 18 and 65 years, at high risk for PONV, undergoing ambulatory plastic surgery under general anesthesia. Exclusion criteria included patient refusal, given other anti-emetics prior to their procedure, history of allergy or sensitivity to study drugs, pregnancy, chronic opioid use, and surgery under intravenous (iv) sedation.

Participant milestones

Participant milestones
Measure
Group A(Oral Aprepitant+iv Ondansetron)
oral aprepitant 40 mg plus intravenous ondansetron 4 mg
Group B(Oral Placebo+iv Ondansetron)
oral placebo plus intravenous ondansetron 4 mg IV
Overall Study
STARTED
75
75
Overall Study
COMPLETED
75
75
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group A(Oral Aprepitant+iv Ondansetron)
n=75 Participants
oral aprepitant 40 mg plus intravenous ondansetron 4 mg
Group B(Oral Placebo+iv Ondansetron)
n=75 Participants
oral placebo plus intravenous ondansetron 4 mg IV
Total
n=150 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
75 Participants
n=5 Participants
75 Participants
n=7 Participants
150 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
43.7 years
STANDARD_DEVIATION 14.3 • n=5 Participants
45.3 years
STANDARD_DEVIATION 16.3 • n=7 Participants
44.5 years
STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male
Female
70 Participants
n=5 Participants
70 Participants
n=7 Participants
140 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Region of Enrollment
United States
75 participants
n=5 Participants
75 participants
n=7 Participants
150 participants
n=5 Participants
Emesis
75 participants
n=5 Participants
75 participants
n=7 Participants
150 participants
n=5 Participants

PRIMARY outcome

Timeframe: 48 hours post surgery

Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS\>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.

Outcome measures

Outcome measures
Measure
Group A(Oral Aprepitant+iv Ondansetron)
n=75 Participants
oral aprepitant 40 mg plus intravenous ondansetron 4 mg
Group B(Oral Placebo+iv Ondansetron)
n=75 Participants
oral placebo plus intravenous ondansetron 4 mg IV
Number of Participants Having Post-operative Emesis and Nausea.
7 participants
22 participants

Adverse Events

Group A(Oral Aprepitant+iv Ondansetron)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group B(Oral Placebo+iv 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

Manuel C. Vallejo, MD

University of Pittsburgh

Phone: 412-641-4260

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place