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The Effects of Gabapentin Premedication on Neurosurgery

NCT ID: NCT02306278

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-14

Study Completion Date

2016-06-30

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.

Conditions

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Cerebral Tumor

Keywords

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gabapentin postoperative pain vomiting nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamin capsules

vitamin capsules orally at the night before operation and 2 hours before surgery,respectively

Group Type PLACEBO_COMPARATOR

vitamin capsules

Intervention Type DRUG

vitamin B

gabapentin

gabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively

Group Type EXPERIMENTAL

gabapentin

Intervention Type DRUG

gabapentin capsules 0.3g

Interventions

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gabapentin

gabapentin capsules 0.3g

Intervention Type DRUG

vitamin capsules

vitamin B

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhang

attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ru Quan Han, chief

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

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Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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ky2013-008-01

Identifier Type: -

Identifier Source: org_study_id