TY - JOUR
T1 - General Anesthesia versus Local Anesthesia in StereotaXY (GALAXY) for Parkinson's disease: study protocol for a randomized controlled trial
AU - Holewijn, R. A.
AU - Verbaan, D.
AU - de Bie, R. M. A.
AU - Schuurman, P. R.
PY - 2017
Y1 - 2017
N2 - Background: The aim of the study is to investigate if deep brain stimulation (DBS) in the subthalamic nucleus (STN) for Parkinson's disease (PD) under general anesthesia further improves outcome by lessening postoperative cognitive, mood, and behavioral adverse effects; shorten surgical time and hospital admittance; and produce comparable symptomatic and functional improvement to surgery under local anesthesia. Methods/design: The study will be a single-center, prospective, randomized, open-label, blinded endpoint trial comparing DBS under general anesthesia with DBS under local anesthesia. The primary outcome measure is a composite score of the postoperative cognitive, mood, and behavioral adverse effects and will be measured 6 months after surgery. The secondary outcome measures consist of changes in motor symptoms, adverse effects of stimulation and surgical complications, surgical time, functional health, quality of life, patient satisfaction with the outcome of treatment, patient evaluation of the burden of therapy, and medication. A total of 110 patients with advanced PD who are candidates for DBS will be randomized during a 2.5-year period. Discussion: The aim of this trial is to further enhance the effectiveness of DBS treatment in PD while reducing the burden of DBS surgery by studying if DBS surgery under general anesthesia results in less cognitive, mood, and behavioral adverse effects compared with surgery under local anesthesia
AB - Background: The aim of the study is to investigate if deep brain stimulation (DBS) in the subthalamic nucleus (STN) for Parkinson's disease (PD) under general anesthesia further improves outcome by lessening postoperative cognitive, mood, and behavioral adverse effects; shorten surgical time and hospital admittance; and produce comparable symptomatic and functional improvement to surgery under local anesthesia. Methods/design: The study will be a single-center, prospective, randomized, open-label, blinded endpoint trial comparing DBS under general anesthesia with DBS under local anesthesia. The primary outcome measure is a composite score of the postoperative cognitive, mood, and behavioral adverse effects and will be measured 6 months after surgery. The secondary outcome measures consist of changes in motor symptoms, adverse effects of stimulation and surgical complications, surgical time, functional health, quality of life, patient satisfaction with the outcome of treatment, patient evaluation of the burden of therapy, and medication. A total of 110 patients with advanced PD who are candidates for DBS will be randomized during a 2.5-year period. Discussion: The aim of this trial is to further enhance the effectiveness of DBS treatment in PD while reducing the burden of DBS surgery by studying if DBS surgery under general anesthesia results in less cognitive, mood, and behavioral adverse effects compared with surgery under local anesthesia
U2 - https://doi.org/10.1186/s13063-017-2136-8
DO - https://doi.org/10.1186/s13063-017-2136-8
M3 - Article
C2 - 28882161
SN - 1745-6215
VL - 18
SP - 417
JO - Trials
JF - Trials
IS - 1
ER -