Postoperative Nausea and Vomiting
Conditions
Brief summary
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.
Detailed description
Postoperative nausea and vomiting (PONV) in the postanesthesia care unit is a common occurrence after general anesthesia. And laparoscopic gynecological surgery is associated with a high incidence of PONV. Several antiemetic agents such as dopaminergic, histaminic and 5-HT3 antagonist (including ondansetron, ramosetron, granisetron) have been used to prevent PONV. Gabapentin, anti-convulsant, has been shown to decrease PONV, as well as chemotherapy induced nausea and vomiting in recent studies, although the exact mechanism against PONV is not known. The purpose of this study was to compare the efficacy of gabapentin and ramosetron in preventing PONV in patients undergoing laparoscopic gynecological surgery.
Interventions
DRUGGabapentin
oral gabapentin 300 mg 1 hour before induction of anesthesia
DRUGRamosetron
ramosetron 0.3 mg iv at end of surgery
DRUGGabapentin and Ramosetron
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
Sponsors
Hallym University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with ASA physical status 1 and 2 between 20 and 65 years undergoing laparoscopic gynecological surgery with patient-controlled analgesia for postoperative pain control.
Exclusion criteria
* Pregnant women * Patients who took sedatives, antiemetics, hypnotics, analgesics, steroid, or gabapentin * Patients with neurological deficits * Patients with history of drug abuse and allergy of study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 48 hours postoperative | The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of nausea | 48 hours postoperative | The severity of nausea will be assessed using verbal rating scales (VRS 11-points scales: 0=no nausea to 10=nausea as bad as it could be) |
| pain score | 48 hours postoperative | The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe) |
| sedation score | 48 hours postoperative | The sedation score will be assessed using verbal rating scales (VRS 11-points scales:0=none to 10=most severe) |
| patient's overall satisfaction score | 48 hours postoperative | The patient's overall satisfaction score will be assessed using 5 point scales (5=very satisfied, 4=somewhat satisfied, 3=neither satisfied nor dissatisfied, 2=somewhat dissatisfied, 1=very dissatisfied) |
| side effects | 48 hours postoperative | The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated |
Countries
South Korea
Contacts
Primary ContactKyung Mi Kim, M.D.
Backup ContactSoo Kyung Lee, Ph.D.
Outcome results
None listed