Postoperative Nausea and Vomiting
Conditions
Keywords
Palonosetron, Craniotomy, Nausea, Vomiting
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.
Interventions
DRUGPalonosetron 0.075 mg IV
At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
DRUGDexamethasone 10 mg IV
At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
DRUGPromethazine 25 mg IV
At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
Sponsors
Eisai Inc.
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PONV Incidence | 24 hours after end of surgery | The incidence of PONV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Subjects Significant QTc Changes in the EKG | 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 |
Participant flow
Pre-assignment details
54 participants provided written consent for the study, and only 40 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Triple Therapy PONV Prohylaxis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
PONV Incidence
The incidence of PONV
Time frame: 24 hours after end of surgery
Population: Incidence of PONV
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triple Therapy PONV Prohylaxis | PONV Incidence | 12 participants |
Secondary
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
Time frame: 24 and 120 hours/discharge after end of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triple Therapy PONV Prohylaxis | Incidence of Subjects Significant QTc Changes in the EKG | 0 participants |