Trial Outcomes & Findings for Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy (NCT NCT00734929)

Results Overview

Any vomiting or retching

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

115 participants

Primary outcome timeframe

48 h

Results posted on

2017-03-13

Participant Flow

The study took place at Duke University Medical Center from September 2007 to June 2009, 146 signed the consent form, 115 were randomized, 104 completed the study

Participant milestones

Participant milestones
Measure	Aprepitant Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Overall Study STARTED	57	58
Overall Study COMPLETED	51	53
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Aprepitant Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Overall Study Lost to Follow-up	1	2
Overall Study No intervention/ screen fail	5	3

Baseline Characteristics

Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aprepitant n=57 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=58 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=93 Participants	58 Participants n=4 Participants	115 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	51 years STANDARD_DEVIATION 13 • n=93 Participants	48 years STANDARD_DEVIATION 13 • n=4 Participants	50 years STANDARD_DEVIATION 13 • n=27 Participants
Sex/Gender, Customized Female	34 participants n=93 Participants	30 participants n=4 Participants	64 participants n=27 Participants
Sex/Gender, Customized Male	22 participants n=93 Participants	29 participants n=4 Participants	51 participants n=27 Participants
Region of Enrollment United States	57 participants n=93 Participants	58 participants n=4 Participants	115 participants n=27 Participants

PRIMARY outcome

Timeframe: 48 h

Population: ITT analysis

Any vomiting or retching

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Cumulative Incidence of Emesis	8 participants	20 participants

SECONDARY outcome

Timeframe: Post operative procedure (OP) hours (0-2, 24, 48)

operative procedure

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Incidence of Nausea 0-2 hours Post OP	27 participants	27 participants
Incidence of Nausea 24 Hours Post Op	33 participants	30 participants
Incidence of Nausea 48 Hours Post Op	35 participants	32 participants

SECONDARY outcome

Timeframe: Post OP (0 - 2 hours)

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Incidence of Vomiting (Post OP)	3 participants	11 participants

SECONDARY outcome

Timeframe: 24 h

Population: ITT analysis

Any vomiting or retching

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Incidence of Vomiting (24 Hours)	7 participants	19 participants

SECONDARY outcome

Timeframe: Post OP (0 - 2 hours)

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Use of Rescue Antiemetics (Post OP)	20 participants	24 participants

SECONDARY outcome

Timeframe: 24 h

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Use of Rescue Antiemetics (24 Hours)	31 participants	30 participants

SECONDARY outcome

Timeframe: 48 hour

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Use of Rescue Antiemetics (48 Hours)	33 participants	32 participants

SECONDARY outcome

Timeframe: 24 hours Post OP, 48 hours Post OP

complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Number of Participants With a Complete Response Rate 48 Hours Post OP	11 participants	19 participants
Number of Participants With a Complete Response Rate 24 Hours Post OP	14 participants	21 participants

SECONDARY outcome

Timeframe: Post OP hours 0-2, 24 h, 48 h

Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Average Nausea Score 0-2 hours post op	0.4 units on a scale Interval 0.0 to 2.8	0.6 units on a scale Interval 0.0 to 2.4
Average Nausea Score 24 hours post op	0.8 units on a scale Interval 0.0 to 3.2	1.3 units on a scale Interval 0.0 to 2.8
Average Nausea Score 48 hours post op	0.9 units on a scale Interval 0.0 to 3.2	1.1 units on a scale Interval 0.0 to 3.3

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Number of Vomiting Episodes	0 vomiting episodes Interval 0.0 to 0.0	0 vomiting episodes Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 48 h

Population: The analysis population only includes participants who had vomiting and had a complete data set

Outcome measures

Outcome measures
Measure	Aprepitant n=6 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=19 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Time to First Vomiting	13.5 hours Interval 0.5 to 28.9	2 hours Interval 0.5 to 19.3

SECONDARY outcome

Timeframe: 48 hour

Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)

Outcome measures

Outcome measures
Measure	Aprepitant n=51 Participants Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia	Ondansetron n=53 Participants Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"	36 participants	32 participants

Adverse Events

Aprepitant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Dr. Ashraf Habib

Duke University Medical Center

Phone: 9196686265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place