Trial Outcomes & Findings for Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant (NCT NCT02597907)

NCT ID: NCT02597907

Last Updated: 2017-04-25

Results Overview

The incidence of postoperative nausea and vomiting during 24 hours postoperatively

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 88 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2017-04-25

Participant Flow

Participant milestones

Measure	Aprepitant Plus Ramosetron aprepitant 80 mg ramosetron 0.3 mg aprepitant: aprepitant 80 mg is given to all patients before surgery Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia	Aprepitant Plus Palonosetron aprepitant 80 mg palonosetron 0.075 mg aprepitant: aprepitant 80 mg is given to all patients before surgery palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia
Overall Study STARTED	44	44
Overall Study COMPLETED	44	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Aprepitant Plus Palonosetron n=44 Participants aprepitant 80 mg palonosetron 0.075 mg aprepitant: aprepitant 80 mg is given to all patients before surgery palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia	Aprepitant Plus Ramosetron n=44 Participants aprepitant 80 mg ramosetron 0.3 mg aprepitant: aprepitant 80 mg is given to all patients before surgery Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=88 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=44 Participants	44 Participants n=44 Participants	88 Participants n=88 Participants
Age, Categorical >=65 years	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=88 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 10.6 • n=44 Participants	48.8 years STANDARD_DEVIATION 10.2 • n=44 Participants	48.8 years STANDARD_DEVIATION 10.2 • n=88 Participants
Sex: Female, Male Female	44 Participants n=44 Participants	44 Participants n=44 Participants	88 Participants n=88 Participants
Sex: Female, Male Male	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=88 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Korea, Republic of	44 Participants n=44 Participants	44 Participants n=44 Participants	88 Participants n=88 Participants

PRIMARY outcome

Timeframe: 24 hours

The incidence of postoperative nausea and vomiting during 24 hours postoperatively

Outcome measures

Measure	Aprepitant Plus Palonosetron n=44 Participants aprepitant 80 mg palonosetron 0.075 mg aprepitant: aprepitant 80 mg is given to all patients before surgery palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia	Aprepitant Plus Ramosetron n=44 Participants aprepitant 80 mg ramosetron 0.3 mg aprepitant: aprepitant 80 mg is given to all patients before surgery Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia
The Incidence of Postoperative Nausea and Vomiting	5 Participants	18 Participants

Adverse Events

Aprepitant Plus Palonosetron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aprepitant Plus Ramosetron

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 Younghoon Jeon

Kyungpook National University

Phone: 82534205871

Email: jeon68@gmail.com

Results disclosure agreements

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