The Effects of Gabapentin Premedication on Neurosurgery

NCT02306278 | Completed DMC

• 1 other identifier: ky2013-008-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Tumor

Keywords

gabapentin; postoperative pain; vomiting; nausea

Outcome Measures

Primary Outcomes (1)

• Premedication gabapentin can decrease pain in early postoperative period

  postoperative pain scores(Visual Analogue Scale)

  24 hour after extubation

Secondary Outcomes (2)

• Premedication gabapentin can limit the development of persistent pain and neuropathic pain.

  3-mos and 6-mos after surgery

• Preoperative gabapentin can lead to a decrease incidence of PONV

  1 hour,2 hours,1day,2 days after surgery

Other Outcomes (1)

• The gabapentin-related effects on neurosurgical patients

  1 hour,2 hours,1day,2 days after surgery

Study Arms (2)

vitamin capsules

PLACEBO COMPARATOR

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

Drug: vitamin capsules

gabapentin

EXPERIMENTAL

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

Drug: gabapentin

Interventions

gabapentin DRUG

gabapentin capsules 0.3g

gabapentin

vitamin capsules DRUG

vitamin B

vitamin capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, ASA physical status I or II, BMI\<30
• Scheduled for elective craniotomy
• Cooperative and given informed consent in person

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Vomiting; Nausea

Interventions

Gabapentin; Vitamins

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ru Quan Han, chief

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: December 3, 2014
• Study Start: December 14, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

CN (1)