Trial Outcomes & Findings for Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV (NCT NCT00952133)

Results Overview

A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

118 participants

Primary outcome timeframe

Pre-op through 72 hours post emergence from anesthesia

Results posted on

2015-04-17

Participant Flow

Recruitment from July 2010 until December 2011 in pre-surgical clinic and in same day surgery.

Participant milestones

Participant milestones
Measure	Palonosetron With Dexamethasone Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.	Palonosetron With Placebo Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
Overall Study STARTED	59	59
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palonosetron With Dexamethasone n=59 Participants Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.	Palonosetron Only n=59 Participants Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=39 Participants	59 Participants n=41 Participants	118 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	35.2 years STANDARD_DEVIATION 8.8 • n=39 Participants	36.2 years STANDARD_DEVIATION 8.1 • n=41 Participants	35.7 years STANDARD_DEVIATION 8.4 • n=35 Participants
Sex: Female, Male Female	48 Participants n=39 Participants	52 Participants n=41 Participants	100 Participants n=35 Participants
Sex: Female, Male Male	11 Participants n=39 Participants	7 Participants n=41 Participants	18 Participants n=35 Participants
Region of Enrollment United States	59 participants n=39 Participants	59 participants n=41 Participants	118 participants n=35 Participants

PRIMARY outcome

Timeframe: Pre-op through 72 hours post emergence from anesthesia

A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.

Outcome measures

Outcome measures
Measure	Palonosetron With Dexamethasone n=59 Participants Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.	Palonosetron Only n=59 Participants Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
Complete Response Rate 0-2 Hours - no rescue medication	38 participants	38 participants
Complete Response Rate 0-6 Hours - no rescue medication	32 participants	32 participants
Complete Response Rate 0-72 Hours - no rescue medication	32 participants	26 participants

SECONDARY outcome

Timeframe: Pre-op through 96 hours post-op

Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery.

Outcome measures

Outcome measures
Measure	Palonosetron With Dexamethasone n=59 Participants Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.	Palonosetron Only n=59 Participants Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery	32 participants	26 participants

Adverse Events

Palonosetron With Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Palonosetron Only

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

Jeanna Blitz, MD

NYU Langone Medical Center

Phone: 212-263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place