Local Anesthesia Thoracoscopy with versus without Midazolam: A Randomized Controlled Trial

Abstract

<b><i>Background:</i></b> Medical thoracoscopy is the gold standard for the diagnosis of pleural diseases. To date, no consensus exists regarding the choice of sedative and analgesic agents in patients undergoing local anesthetic thoracoscopy (LAT), and questions are raised as to whether sedatives may add to respiratory side effects. <b><i>Objective:</i></b> The aim of the study was to test the hypothesis that administration of midazolam associated with lidocaine versus lidocaine alone in patients with LAT adds to respiratory side effects. <b><i>Methods:</i></b> We randomly assigned 80 patients to a 1:1 study to 2 groups: local anesthesia by lidocaine (<i>n</i> = 40) versus lidocaine and midazolam (<i>n</i> = 40), with the primary end point being the mean lowest oxygen saturation. The secondary end points were cardiovascular parameters, complications, days of drainage, hospital stay, and patients’ quality of life (QoL) as assessed by a visual analog scale (VAS). <b><i>Results:</i></b> The mean age of all patients was 66.6 ± 13.1 years. The study comprised 50 males (62.5%). No difference was observed in the demographics between the 2 groups. No significant difference was observed between the 2 groups in oxygen saturation (primary end point). A significant difference was observed in favor of the midazolam group regarding the QoL assessed by VAS. <b><i>Conclusion:</i></b> Midazolam does not add to respiratory side effects when it is used with lidocaine for LAT, while patients’ QoL is actually improved in this group. Therefore, in our department, we changed our startegy in favor of the association of lidocaine and midazolam.

Review of the Physiology and Anesthetic Considerations for Pleuroscopy/Medical Thoracoscopy

“…A recently published randomized, noninferiority trial of 80 patients compared LA alone versus LA with midazolam for pleuroscopy, concluding that midazolam does not contribute to respiratory side effects perioperatively [27]. Not only comparable oxygen saturations between the 2 groups were observed but midazolam was also associated with lower cough scores (7 ± 13 vs. 18 ± 23, p = 0.015) and lower pain scores (Visual Analog Scale [VAS] scores: 24 ± 23 vs. 38 ± 24, p = 0.015) at the end of the procedure.…”

“…Although sedation is an indispensable part of pleuroscopy, the latter may be performed under LA with or even without sedation [13,116,117]. In fact, in some centers, pleuroscopy is carried out under LA as a standard technique [27]. The avoidance of sedation may be justifiable since it may be associated with some complications (airway obstruction, hypoxic events, respiratory depression, hypotension, nausea, or vomiting) that might be unavoidable even by experienced physicians [30].…”

“…To our knowledge, there are no studies in the current literature designed to compare LA alone versus LA and sedation for pleuroscopy, except one [27]. As stated before, in the light of the positive results in favor of midazolam (lower cough and pain scores, lower scores for discomfort, fear, or willingness to repeat the procedure), the authors changed their strategy, adding small doses of midazolam in pleuroscopy.…”