Trial Outcomes & Findings for Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis (NCT NCT02635828)

NCT ID: NCT02635828

Last Updated: 2017-05-05

Results Overview

The incidence of PONV

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

24 hours after end of surgery

Results posted on

2017-05-05

Participant Flow

54 participants provided written consent for the study, and only 40 participants were randomized.

Participant milestones

Participant milestones
Measure	Triple Therapy PONV Prohylaxis At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis. Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis. Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
Overall Study STARTED	54
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triple Therapy PONV Prohylaxis n=40 Participants At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis. Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis. Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Sex: Female, Male Female	21 Participants n=99 Participants
Sex: Female, Male Male	19 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	39 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 24 hours after end of surgery

Population: Incidence of PONV

The incidence of PONV

Outcome measures

Outcome measures
Measure	Triple Therapy PONV Prohylaxis n=40 Participants At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis. Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis. Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
PONV Incidence	12 participants

SECONDARY outcome

Timeframe: 24 and 120 hours/discharge after end of surgery

The incidence of significant QTc prolongation was measured by comparing baseline EKG, 24 hours and 120 hours after surgery

Outcome measures

Outcome measures
Measure	Triple Therapy PONV Prohylaxis n=40 Participants At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis. Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis. Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
Incidence of Subjects Significant QTc Changes in the EKG	0 participants

Adverse Events

Triple Therapy PONV Prohylaxis

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

Director of Neuroanesthesia

The Ohio State Universtiy Wexner Medical Center

Phone: 6142933559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place