Trial Outcomes & Findings for Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery (NCT NCT01510379)

NCT ID: NCT01510379

Last Updated: 2014-03-05

Results Overview

Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2014-03-05

Participant Flow

Recruitment occurred at The Ohio State University Wexner Medical Center over a 1 year period.

Enrolled participants were not excluded from the trial before assignment to groups.

Participant milestones

Measure	Reletex Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.	Control Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
Overall Study STARTED	49	51
Overall Study COMPLETED	49	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery

Baseline characteristics by cohort

Measure	Reletex n=49 Participants Reletex plus scheduled ondansetron and phenergan prn	Control n=51 Participants Scheduled ondansetron plus phenergan prn	Total n=100 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	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 14.22 • n=5 Participants	58 years STANDARD_DEVIATION 16.16 • n=7 Participants	57 years STANDARD_DEVIATION 15.17 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).

Outcome measures

Measure	Reletex n=49 Participants Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.	Control n=51 Participants Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.	1.81 units on a scale Standard Deviation 2.17 • Interval 0.0 to 10.0	2.03 units on a scale Standard Deviation 2.83 • Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: one week

Outcome measures

Measure	Reletex n=49 Participants Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.	Control n=51 Participants Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
Quantify the Amounts of Phenergan Used Between the Two Groups.	42 mg Standard Deviation 75.6	57.6 mg Standard Deviation 128.2

Adverse Events

Reletex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Kyle A. Perry, MD

The Ohio State University

Phone: 614-293-5815

Email: kyle.perry@osumc.edu

Results disclosure agreements

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