Trial Outcomes & Findings for Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting (NCT NCT00717054)

NCT ID: NCT00717054

Last Updated: 2014-05-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 115 participants
• Primary outcome timeframe: 24 hours postoperatively
• Results posted on: 2014-05-20

Participant Flow

Participant milestones

Measure	Aprepitant and Scopolamine Group Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Aprepitant and Placebo Scopolamine Group Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Overall Study STARTED	58	57
Overall Study COMPLETED	58	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Baseline characteristics by cohort

Measure	Aprepitant and Scopolamine Group n=58 Participants Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Aprepitant and Placebo Scopolamine Group n=57 Participants Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Total n=115 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 11.06 • n=93 Participants	47.2 years STANDARD_DEVIATION 11.27 • n=4 Participants	46.8 years STANDARD_DEVIATION 11.17 • n=27 Participants
Sex: Female, Male Female	51 Participants n=93 Participants	52 Participants n=4 Participants	103 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours postoperatively

Outcome measures

Measure	Aprepitant and Scopolamine Group n=58 Participants Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Aprepitant and Placebo Scopolamine Group n=57 Participants Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Number of Participants With Nausea and Vomiting	24 participants	29 participants

SECONDARY outcome

Timeframe: Postoperatively, up to 2 hours

Outcome measures

Measure	Aprepitant and Scopolamine Group n=58 Participants Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Aprepitant and Placebo Scopolamine Group n=57 Participants Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Number of Participants With Nausea and Vomiting in PACU	35 participants	39 participants

SECONDARY outcome

Timeframe: 24 hours postoperatively

Outcome measures

Measure	Aprepitant and Scopolamine Group n=58 Participants Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Aprepitant and Placebo Scopolamine Group n=57 Participants Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Total Vomiting	5 participants	2 participants

SECONDARY outcome

Timeframe: 24 hours postoperatively

Outcome measures

Measure	Aprepitant and Scopolamine Group n=58 Participants Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Aprepitant and Placebo Scopolamine Group n=57 Participants Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Need for Antiemetic Medication	23 participants	21 participants

Adverse Events

Aprepitant and Scopolamine Group

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Aprepitant and Scopolamine Placebo Group

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aprepitant and Scopolamine Group n=58 participants at risk Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events. Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery	Aprepitant and Scopolamine Placebo Group n=57 participants at risk Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events. Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
General disorders Dry mouth	58.6% 34/58 • Number of events 34 • 1 year	50.9% 29/57 • Number of events 29 • 1 year

Additional Information

Michael Green, DO

Drexel University College of Medicine

Phone: 215-762-7798

Email: michael.green@drexelmed.edu

Results disclosure agreements

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