The Effects of Gabapentin Premedication on Neurosurgery
Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Tumor
Intervention: gabapentin (Drug); vitamin capsules (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Capital Medical University Official(s) and/or principal investigator(s): Ru Quan Han, chief, Study Chair, Affiliation: Beijing Tiantan Hospital
Overall contact: Min Zeng, attending, Phone: 8610-67096658, Email: fly800727@163.com
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.
Clinical Details
Official title: The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Premedication gabapentin can decrease pain in early postoperative periodPremedication gabapentin can decrease pain in early postoperative period Premedication gabapentin can decrease pain in early postoperative period Premedication gabapentin can decrease pain in early postoperative period
Secondary outcome: Preoperative gabapentin can lead to a decrease incidence of PONV
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 and
2days 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Min Zeng, attending, Phone: 8610-67096658, Email: fly800727@163.com
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing 100050, China; Recruiting Min Zeng, MD, Phone: 8610-67096658, Email: fly800727@163.com Ru Quan Han, MD, Phone: 8610-67096658, Email: ruquan.han@gmail.com Min Zeng, MD, Principal Investigator
Additional Information
Starting date: April 2014
Last updated: April 25, 2015
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