Deep brain stimulation surgery under ketamine induced conscious sedation: a double blind randomized controlled trial
Bibliographic record
Abstract
Abstract Background The gold standard anesthesia for deep brain stimulation (DBS) surgery is the “awake” approach, using local anesthesia alone. While it offers high-quality microelectrode recordings and clinical assessment of the stimulation therapeutic window, it potentially causes patients extreme stress and might result in suboptimal surgical outcomes. However, the alternative of general anesthesia or deep sedation dramatically reduces reliability of physiological navigation and therapeutic window assessment, thus potentially diminishing the accuracy of lead localization. We therefore designed a prospective double-blinded randomized controlled trial to investigate a novel anesthesia regimen of ketamine-induced conscious sedation for DBS surgery. Methods Patients with Parkinson’s disease undergoing subthalamic nucleus DBS surgery were enrolled. Patients were randomly assigned to either the experimental or control group. During the physiological navigation phase, the experimental group received ketamine infusion at a dosage of 0.25 mg/kg/hr, while the control group received normal saline. Both groups received moderate propofol sedation before and after the physiological navigation phase. Primary outcomes were non-inferiority of electrophysiological quality, including multiunit recordings, EEG, EMG, bispectral index and lead localization accuracy according to postoperative CT scans. Secondary outcomes included patients’ satisfaction level measured using Iowa satisfaction with anesthesia scale for awake procedures. Potential side effects and adverse events were also monitored, including hemodynamics (blood pressure, heart rate) and cognition (hallucinations during surgery and early post-operative cognition using Montreal Cognitive Assessment). Results Thirty patients, 15 from each group, were included in the study and analysed. Intra-operatively, the electrophysiological signature of the subthalamic nucleus was similar under ketamine and saline. Tremor amplitude was slightly lower under ketamine ( p = 0.002). The accuracy of lead position was comparable in both groups. Postoperatively, patients in the ketamine group reported significantly higher satisfaction with anesthesia. The improvement in Unified Parkinson’s disease rating scale part-III was similar between the groups. No negative effects of ketamine on hemodynamic stability or cognition were reported perioperatively. Additionally, no procedure-related complications were reported in either group, besides one case of peri-lead edema in the control group. Conclusion This study demonstrates that ketamine induced conscious sedation during physiological navigation in DBS surgery resulted in non-inferior intra-operative, post-surgical and patient satisfaction outcomes compared to the commonly used standard awake protocol, without major disadvantages. Future studies should investigate the applicability of this protocol in other awake neurosurgical procedures, such as DBS for other targets and indications, and awake craniotomy for tumor resection and epilepsy.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".