The Effects of Gabapentin Premedication on Neurosurgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02306278

Enrollment

122

Registered

2014-12-03

Start date

2014-12-14

Completion date

2016-06-30

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Tumor

Keywords

gabapentin, postoperative pain, vomiting, nausea

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.

Interventions

DRUGgabapentin

gabapentin capsules 0.3g

DRUGvitamin capsules

vitamin B

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
The gabapentin-related effects on neurosurgical patients	1 hour,2 hours,1day,2 days after surgery	Glasgow Score, Ramsay Score , somnolence,dizzy or dry mouth

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026