Dexmedetomidine Versus Midazolam for Sedation During Medical Thoracoscopy: A Pilot Randomized-Controlled Trial (RCT).

Background: Studies comparing the utility of dexmedetomidine with other drugs for sedation during medical thoracoscopy are lacking. In this pilot study, we compared dexmedetomidine with midazolam for sedation in thoracoscopy.

Methods: Consecutive subjects were randomized to receive either dexmedetomidine (n=30) (group D) or midazolam (n=30) (group M). All received fentanyl for procedural analgesia. The primary endpoint was pulmonologist-rated overall procedure satisfaction on the visual analog scale (satisfaction VAS). Key secondary outcomes were pulmonologist-rated cough on VAS (cough VAS), patient-rated faces pain scale scores, change in hemodynamic variables, total additional fentanyl dose, and adverse events during procedure.

Results: The satisfaction VAS score (mean±SD) was significantly greater in group D versus group M (7.5±1.4 and 6.5±1.1, respectively) ( P =0.003). The cough VAS scores (mean±SD) were 2.1±1.5 (group D) and 3.1±1.3 (group M) ( P =0.014). The scores (mean±SD) for patient-rated faces pain scale were 2.9±1.8 and 4.2±2.3 ( P =0.019) in group D and group M, respectively. The additional dose of fentanyl administered in group M was significantly greater than in group D ( P =0.001). The responses at the local anesthesia infiltration, skin incision, thoracoscope insertion, and biopsy between both groups were similar. The hemodynamic parameters were comparable in both groups. Also, more patients were willing for repeat thoracoscopy if needed; in the dexmedetomidine group.

Conclusion: The findings of this pilot RCT indicate that dexmedetomidine may be more efficacious than midazolam for sedation in patients undergoing medical thoracoscopy. These observations need to be confirmed in an adequately powered RCT.