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The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or placebo orally the night before operation day and 2hours before surgery,respectively.The investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be observed in GG than GP.
This is a random, double-blind study. In GG, patients are given gabapentin 600mg orally at the night and 2hours before surgery, respectively. In PG, vitamine pills are given instead.Total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days, 3months and 6months after surgery, patients are evaluated for pain (VAS) and incidence of PONV. In addition,Glasgow Score, Ramsay Score and other gabapentin-related effects, such as somnolence,dizzy or dry mouth are also observed.The incidence of persistent pain and neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin capsules | Placebo Comparator | vitamin capsules orally at the night before operation and 2 hours before surgery,respectively |
|
| gabapentin | Experimental | gabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gabapentin | Drug | gabapentin capsules 0.3g |
| |
| vitamin capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Premedication gabapentin can decrease pain in early postoperative period | postoperative pain scores(Visual Analogue Scale) | 24 hour after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Premedication gabapentin can limit the development of persistent pain and neuropathic pain. | postoperative pain scores(Visual Analogue Scale) and the Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale | 3-mos and 6-mos after surgery |
| Preoperative gabapentin can lead to a decrease incidence of PONV |
| Measure | Description | Time Frame |
|---|---|---|
| The gabapentin-related effects on neurosurgical patients | Glasgow Score, Ramsay Score , somnolence,dizzy or dry mouth | 1 hour,2 hours,1day,2 days after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ru Quan Han, chief | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Drug |
vitamin B |
|
Incidence of PONV |
| 1 hour,2 hours,1day,2 days after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| 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 |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |