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NCT Number: NCT02306278

The Effects of Gabapentin Premedication on Neurosurgery

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.

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Key information

Conditions

Cerebral Tumor Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

gabapentin capsules 0.3g

vitamin capsules

Drug

vitamin B

Primary outcomes

  1. Premedication gabapentin can decrease pain in early postoperative period

    Time frame: 24 hour after extubation

    postoperative pain scores(Visual Analogue Scale)

Secondary outcomes

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

    Time frame: 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

  2. Preoperative gabapentin can lead to a decrease incidence of PONV

    Time frame: 1 hour,2 hours,1day,2 days after surgery

    Incidence of PONV

Other outcomes

  1. The gabapentin-related effects on neurosurgical patients

    Time frame: 1 hour,2 hours,1day,2 days after surgery

    Glasgow Score, Ramsay Score , somnolence,dizzy or dry mouth

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 3, 2014
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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