Postoperative Nausea and Vomiting
Conditions
Brief summary
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
Detailed description
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy. Study is performed during 24 hours after surgery.
Interventions
DRUGaprepitant
aprepitant 80 mg is given to all patients before surgery
DRUGpalonosetron
palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia
DRUGRamosetron
ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia
Sponsors
Kyungpook National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Non smoking, female patients, scheduled for laparoscopic cholecystectomy
Exclusion criteria
* Patients with gastrointestinal disorder, * Patients with allergies to any study medication, * Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Postoperative Nausea and Vomiting | 24 hours | The incidence of postoperative nausea and vomiting during 24 hours postoperatively |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant Plus Palonosetron aprepitant 80 mg palonosetron 0.075 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia | 44 |
| Aprepitant Plus Ramosetron aprepitant 80 mg ramosetron 0.3 mg
aprepitant: aprepitant 80 mg is given to all patients before surgery
Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia | 44 |
| Total | 88 |
Baseline characteristics
| Characteristic | Aprepitant Plus Ramosetron | Total | Aprepitant Plus Palonosetron |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 88 Participants | 44 Participants |
| Age, Continuous | 48.8 years STANDARD_DEVIATION 10.2 | 48.8 years STANDARD_DEVIATION 10.2 | 48.9 years STANDARD_DEVIATION 10.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Korea, Republic of | 44 Participants | 88 Participants | 44 Participants |
| Sex: Female, Male Female | 44 Participants | 88 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
The Incidence of Postoperative Nausea and Vomiting
The incidence of postoperative nausea and vomiting during 24 hours postoperatively
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aprepitant Plus Palonosetron | The Incidence of Postoperative Nausea and Vomiting | 5 Participants |
| Aprepitant Plus Ramosetron | The Incidence of Postoperative Nausea and Vomiting | 18 Participants |
p-value: <0.05Fisher Exact