Clinical trial NCT02306278: The Effects of Gabapentin Premedication on Neurosurgery
Official title: The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Tumor
Keywords: gabapentin
postoperative pain
vomiting
nausea
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Premedication gabapentin can decrease pain in early postoperative period
timeFrame: 24 hour after extubation
Secondary outcomes:
measure: Premedication gabapentin can limit the development of persistent pain and neuropathic pain.
timeFrame: 3-mos and 6-mos after surgery
measure: Preoperative gabapentin can lead to a decrease incidence of PONV
timeFrame: 1 hour,2 hours,1day,2 days after surgery
Other outcomes:
measure: The gabapentin-related effects on neurosurgical patients
timeFrame: 1 hour,2 hours,1day,2 days after surgery
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ru Quan Han, chief
role: STUDY_CHAIR
References: