Six months post-surgery, patients on either general anesthesia or local anesthesia demonstrated similar motor improvements, indicated by scores on the MDS-UPDRS, as well as similar safety findings.
Findings from the single-center, prospective, GALAXY clinical trial (NTR5809) showed no between-group difference in cognitive, mood, and behavioral adverse events, as well as equal improvement in motor function, in patients with Parkinson disease (PD) who underwent deep brain stimulation (DBS) of the subthalamic nucleus with either general (asleep) anesthesia or local (awake) anesthesia.
Senior author Rick Shuurman, MD, PhD, professor of neuroscience, Amsterdam University Medical Centers, and colleagues, collected data on 110 patients with advanced PD and motor response fluctuations who were randomized 1:1 to awake (n = 56) or to asleep (n = 54) DBS surgery, with the primary outcome follow-up visit conducted 6 months after the procedure. The primary outcome was a composite score of cognitive, mood, and behavioral adverse events that was composed of findings in 4 areas (FIGURE).
Primary outcome data was available for 103 patients at the conclusion of the 6-month period. At this time, no differences in the primary outcome were observed between the general and local anesthesia groups. A composite score of 1 or more occurred in 15 of 52 patients (29%) in the local anesthesia group and in 11 of 51 patients (22%) in the general anesthesia group (OR, 0.7 [95% CI, 0.3-1.7]). These results did not change in a multivariable regression model (adjusted OR, 0.7 [95% CI, 0.3-1.7]).
"Our study was not designed or powered to determine whether abandoning clinical testing has a meaningful influence on final electrode placement, but abandoning awake clinical testing does not lead to less motor improvement," the study authors concluded. "The procedure under general anesthesia is much more patient friendly and faster."
Shuurman et al also looked at secondary outcomes that included change in the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), the patient assessment of surgical burden, and operative time. Six months after surgery, the mean improvement in motor symptoms, reflected by change in MDS-UPDRS during the off-medication phase, was not different between the groups. Investigators recorded changes of –27.3 points(standard deviation [SD], 17.5]; 52% improvement) in the local anesthesia group compared with –25.3 points (SD, 14.3; 50% improvement) in the general anesthesia group (mean difference, –2.0 points [95% CI, –8.1 to 4.2]).
Neither group demonstrated an advantage in improvement of subscores of tremor, rigidity, bradykinesia, and gait and balance. The results observed in MDS-UPDRS scores remained did not change in the multivariable regression analysis (ß = 1.1 [95% CI, –3.7 to 5.9]).
Results using a 7-point Likert-type scale, with higher scores representing greater satisfaction, showed that asleep surgery was experienced as less burdensome by patients. The median experienced burden of surgery was 5.0 (interquartile range [IQR], 2.0-7.0]) in the local anesthesia group compared with 1.0 (IQR, 1.0-2.5) in the general anesthesia group (P <.001). Furthermore, the median satisfaction about the outcome of DBS after 6 months was 6.5 (IQR, 6.0-7.0) in the local anesthesia group compared with 7.0 (IQR, 6.0-7.0; P = .23).
Patients in the local anesthesia group had a mean operative time of 323 (SD, 47) minutes compared with 297 (SD, 53) minutes in the general anesthesia group. There was no between-group difference in the number of microelectrode tracks used for the recordings (Mann-Whitney U = 1370.50 [Z = –.0775; P = .44]).