The Effects of Gabapentin Premedication on Neurosurgery

Cerebral Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306278
• Other study ID #: ky2013-008-01
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: October 13, 2017
• Start date: December 14, 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2017
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Tumor

Intervention

Drug:
• gabapentin
gabapentin capsules 0.3g
• vitamin capsules
vitamin B

Locations

Country	Name	City	State
China	Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The gabapentin-related effects on neurosurgical patients	Glasgow Score, Ramsay Score , somnolence,dizzy or dry mouth	1 hour,2 hours,1day,2 days after surgery
Primary	Premedication gabapentin can decrease pain in early postoperative period	postoperative pain scores(Visual Analogue Scale)	24 hour after extubation
Secondary	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
Secondary	Preoperative gabapentin can lead to a decrease incidence of PONV	Incidence of PONV	1 hour,2 hours,1day,2 days after surgery