Trial reportDrug design, development and therapy2026
Dexmedetomidine-Ketamine-Based Multimodal General Anesthesia with Electroencephalographic Spectrogram-Guided Titration Improves Early Recovery After Lumbar Spine Fusion in Older Adults: A Randomized Controlled Trial.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05247177 (Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial
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6 authors.
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Abstract
Background: Older adults undergoing lumbar spine fusion are vulnerable to impaired postoperative recovery and persistent postsurgical pain. Dexmedetomidine-ketamine-based multimodal general anesthesia may reduce volatile anesthetic and opioid exposure, but its efficacy and tolerability in older adults undergoing high-pain spine surgery remain uncertain. This randomized controlled trial evaluated whether electroencephalographic spectrogram-guided multimodal general anesthesia improves early recovery compared with conventional balanced anesthesia. Methods: Patients aged ≥60 years undergoing elective lumbar spine fusion were randomized 1:1 in a parallel-group, superiority design to receive either dexmedetomidine-ketamine-based multimodal general anesthesia guided by electroencephalographic density spectral array monitoring or conventional bispectral index-guided balanced anesthesia. All patients received standardized perioperative care. The primary efficacy outcome was the 24-hour change in Quality of Recovery-15 (QoR-15) score from baseline, analyzed as the between-group difference in mean change score. Secondary outcomes included opioid requirements, 3-month pain outcomes, and safety and tolerability outcomes. All secondary outcomes, including the 3-month pain outcomes, were exploratory. Results: Among 100 randomized patients, 50 were assigned to each group. The multimodal general anesthesia group had a smaller 24-hour decline in QoR-15 score than the control group (-22.5 vs -33.5 points; mean difference, 11.0; 95% confidence interval, 0.8-21.2; p=0.036). Multimodal general anesthesia reduced sevoflurane consumption [28 (22-42) vs 43 (36-53) mL; p<0.001], intraoperative fentanyl dose [150 (100-200) vs 200 (125-250) μg; p=0.003], and post-anesthetic care unit morphine requirement [0 (0-2) vs 2 (0-3) mg; p<0.001], at the expense of increased intraoperative norepinephrine and atropine requirements. No significant between-group differences were observed in postoperative safety outcomes, although the trial was not powered to exclude clinically relevant differences. Exploratory 3-month analyses showed lower average pain intensity in the multimodal general anesthesia group [1 (0-2) vs 2 (0-4); p=0.033], whereas the proportion of pain-free patients did not differ significantly [41.7% vs 28.0%; p=0.203]. Conclusion: Dexmedetomidine-ketamine-based multimodal general anesthesia implemented with spectrogram-guided titration improved early patient-centered recovery and reduced immediate perioperative opioid requirements, at the expense of increased intraoperative vasopressor and atropine use. Exploratory analyses suggested a possible reduction in 3-month average pain intensity, which requires confirmation in trials adequately powered for persistent postsurgical pain. Trial Registration: NCT05247177.
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