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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 period

Premedication 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

Page last updated: August 20, 2015

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