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This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | oral gabapentin 300 mg 1 hours before induction of anesthesia |
|
| ramosetron | Active Comparator | ramosetron 0.3 mg iv at end of surgery |
|
| Gabapentin and ramosetron | Active Comparator | oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | oral gabapentin 300 mg 1 hour before induction of anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting | The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery | 48 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of nausea | 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) | 48 hours postoperative |
| pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung Mi Kim, M.D. | Contact | +82-31-380-3945 | sumsonyo@hallym.or.kr | |
| Soo Kyung Lee, Ph.D. | Contact | +82-31-380-3945 | agneta@hallym.or.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | KS009 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28525981 | Derived | Kim KM, Huh J, Lee SK, Park EY, Lee JM, Kim HJ. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study. BMC Anesthesiol. 2017 May 19;17(1):65. doi: 10.1186/s12871-017-0357-8. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| C071315 | ramosetron |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Ramosetron | Drug | ramosetron 0.3 mg iv at end of surgery |
|
|
| Gabapentin and Ramosetron | Drug | oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery |
|
|
The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe)
| 48 hours postoperative |
| sedation score | The sedation score will be assessed using verbal rating scales (VRS 11-points scales:0=none to 10=most severe) | 48 hours postoperative |
| patient's overall satisfaction score | 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) | 48 hours postoperative |
| side effects | The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated | 48 hours postoperative |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |