The Effects of Gabapentin Premedication on Neurosurgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery

Conditions
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Cerebral Tumor

Intervention / Treatment
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* Drug: gabapentin
* Drug: vitamin capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old, ASA physical status I or II, BMI<30 Scheduled for elective craniotomy Cooperative and given informed consent in person Exclusion Criteria: History of mental or psychiatric disorders Pregnant or lactating female History of systemic malignant tumor or diabetes Previously treated with this protocol or participated in another experimental study within previous 30 days Suspected history of allergic reaction or intolerance to gabapentin or other anesthetic agents in this study History of alcohol abuse and/or drug abuse within previous one year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: vitamin capsules<br>vitamin capsules orally at the night before operation and 2 hours before surgery,respectively | Drug: vitamin capsules<br>* vitamin B<br>|
| Experimental: gabapentin<br>gabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively | Drug: gabapentin<br>* gabapentin capsules 0.3g<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premedication gabapentin can decrease pain in early postoperative period | postoperative pain scores(Visual Analogue Scale) | 24 hour after extubation | 

Secondary Outcome Measures

| Outcome Measure | 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 | Incidence of PONV | 1 hour,2 hours,1day,2 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gabapentin, postoperative pain, vomiting, nausea