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Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Palonosetron 0.075 mg IV

Dexamethasone 10 mg IV

Promethazine 25 mg IV

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Palonosetron, Craniotomy, Nausea, Vomiting

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients, 18 to 85 years of age, of any race or gender. With an American Society of Anesthesiologist (ASA) physical status of I to III who are scheduled to undergo neurological surgery requiring opening of the cranium and Dura matter under general anesthesia, at Ohio State University Medical Center and who consent in writing to participating in this study.
Post operative hospitalization expected to last at least 72 hours.
Subjects whose surgery is expected to require at least 1 hours of general anesthesia
Subjects who have a negative serum or urine pregnancy test within 1 day of surgery or who have been surgically sterilized or are postmenopausal.

Exclusion Criteria:

Subjects who are prisoners, pregnant, mentally ill, under the age of 18 or over the age of 85, ASA classification of V, alcohol or drug abusers.
Subjects with known hypersensitivity to any 5-HT3 antagonist, to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol.
Subjects who are breastfeeding.
Subjects who have had retching/vomiting or moderate to severe nausea in the 24 hours prior to anesthesia or suffer chronic nausea and/or vomiting
Subjects who have been treated with any drug or other treatment with anti-emetic efficacy within the last 24 hours prior to the start of treatment.
Subjects who have participated in a clinical trial of an investigational drug within 30 days prior to surgery.
Subjects who are participating in any other clinical study

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triple therapy PONV prophylaxis

Arm Description

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.

Outcomes

Primary Outcome Measures

PONV Incidence

The incidence of PONV

Secondary Outcome Measures

Incidence of Subjects Significant QTc Changes in the EKG

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

Full Information

NCT ID

NCT02635828

First Posted

December 8, 2015

Last Updated

March 24, 2017

Sponsor

Ohio State University

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02635828

Brief Title

Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

Official Title

Studying the Effectiveness of Triple Therapy With Palonosetron, Dexamethasone and Promethazine for Prevention of Post Operative Nausea and Vomiting in High Risk Patients Undergoing Neurological Surgery and General Anesthesia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

Collaborators

Eisai Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.

Detailed Description

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. After surgery, subjects were transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via direct interview and/or medical charts review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

Palonosetron, Craniotomy, Nausea, Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Triple therapy PONV prophylaxis

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Palonosetron 0.075 mg IV

Other Intervention Name(s)

Aloxi

Intervention Description

At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone 10 mg IV

Other Intervention Name(s)

Decadron

Intervention Description

At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.

Intervention Type

Drug

Intervention Name(s)

Promethazine 25 mg IV

Other Intervention Name(s)

Phenergan

Intervention Description

At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.

Primary Outcome Measure Information:

Title

PONV Incidence

Description

The incidence of PONV

Time Frame

24 hours after end of surgery

Secondary Outcome Measure Information:

Title

Incidence of Subjects Significant QTc Changes in the EKG

Description

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

Time Frame

24 and 120 hours/discharge after end of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients, 18 to 85 years of age, of any race or gender. With an American Society of Anesthesiologist (ASA) physical status of I to III who are scheduled to undergo neurological surgery requiring opening of the cranium and Dura matter under general anesthesia, at Ohio State University Medical Center and who consent in writing to participating in this study. Post operative hospitalization expected to last at least 72 hours. Subjects whose surgery is expected to require at least 1 hours of general anesthesia Subjects who have a negative serum or urine pregnancy test within 1 day of surgery or who have been surgically sterilized or are postmenopausal. Exclusion Criteria: Subjects who are prisoners, pregnant, mentally ill, under the age of 18 or over the age of 85, ASA classification of V, alcohol or drug abusers. Subjects with known hypersensitivity to any 5-HT3 antagonist, to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol. Subjects who are breastfeeding. Subjects who have had retching/vomiting or moderate to severe nausea in the 24 hours prior to anesthesia or suffer chronic nausea and/or vomiting Subjects who have been treated with any drug or other treatment with anti-emetic efficacy within the last 24 hours prior to the start of treatment. Subjects who have participated in a clinical trial of an investigational drug within 30 days prior to surgery. Subjects who are participating in any other clinical study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alberto A Uribe, M.D.

Organizational Affiliation

The Ohio State University Wexner Medical Center

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared with other researchers.

Citations:

PubMed Identifier

10475299

Citation

Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.

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Citation

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Citation

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Citation

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Results Reference

derived

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Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

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