The Effects of Gabapentin Premedication on Neurosurgery

Not Applicable

Completed

• Conditions: Cerebral Tumor
• Interventions: Drug: vitamin capsules; Drug: gabapentin

• Registration Number: NCT02306278
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Study Start: 2014-12-14
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin capsules	vitamin capsules	vitamin capsules orally at the night before operation and 2 hours before surgery,respectively
gabapentin	gabapentin	gabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively

Primary Outcome Measures

Name	Time	Method
Premedication gabapentin can decrease pain in early postoperative period	24 hour after extubation	postoperative pain scores(Visual Analogue Scale)

Secondary Outcome Measures

Name	Time	Method
Premedication gabapentin can limit the development of persistent pain and neuropathic pain.	3-mos and 6-mos after surgery	postoperative pain scores(Visual Analogue Scale) and the Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale
Preoperative gabapentin can lead to a decrease incidence of PONV	1 hour,2 hours,1day,2 days after surgery	Incidence of PONV

Trial Locations

Locations (1)

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China