A Prospective Comparative Non-randomized Study of Ketofol Versus Midazolam Sedation in Flexible Bronchoscopy

Background Flexible bronchoscopy requires reliable sedation that preserves respiratory drive while ensuring patient comfort and procedural efficiency. Midazolam, a benzodiazepine, is widely employed but is associated with respiratory depression, unpredictable recovery kinetics, and compromised oxygenation, particularly in patients with underlying pulmonary disease. Ketofol, a fixed-ratio admixture of ketamine and propofol, exploits the pharmacodynamic complementarity of its constituents: ketamine maintains airway reflexes and sympathetic tone, while propofol confers rapid-onset sedation and swift recovery. Head-to-head comparative evidence for ketofol versus midazolam in flexible bronchoscopy remains limited. Methods This prospective comparative non-randomized study enrolled 80 adult patients scheduled for flexible bronchoscopy at the Department of Respiratory Medicine, Santiniketan Medical College Hospital. Allocation to the ketofol group (n = 40) or the midazolam group (n = 40) was determined by the treating bronchoscopist in consultation with the attending anesthesiologist before the procedure, based on clinical judgment, anticipated airway tolerance, procedural requirements, comorbidity profile, and operator familiarity with the sedative regimen. A standardized pre-procedure assessment form was used, and the sedation choice was documented before bronchoscope insertion. Because of the observational nature of the study, no randomization, allocation concealment, or blinding was employed. Continuous monitoring included pulse oximetry, non-invasive blood pressure, and electrocardiography. Primary endpoints were the incidence of intraoperative cough events and desaturation episodes (SpO₂ < 90%). Secondary endpoints encompassed sedation depth (Richmond Agitation-Sedation Scale (RASS)), physician and patient satisfaction (5-point Likert scale), procedure duration, recovery time, and supplemental dose requirements. Results Baseline demographic and clinical characteristics were comparable between groups. Ketofol was associated with fewer cough events (2.1 ± 1.0 vs. 5.2 ± 1.6; p < 0.001) and lower rates of oxygen desaturation (5% vs. 60%; p < 0.00001). Physician and patient satisfaction scores were higher with ketofol (4.6 and 4.5, respectively) compared with midazolam (3.0 and 3.1). Procedure duration (12 ± 3 vs. 18 ± 4 min) and recovery time (13 ± 3 vs. 33 ± 10 min) were shorter in the ketofol group. No serious adverse events were recorded in either arm. Conclusion In this prospective comparative non-randomized study, ketofol sedation was associated with lower rates of oxygen desaturation, reduced cough frequency, shorter recovery times, and higher physician and patient satisfaction compared with midazolam during flexible bronchoscopy. These findings suggest that ketofol may provide favorable procedural and respiratory outcomes in selected patients undergoing bronchoscopy. However, larger randomized controlled trials are required to further validate these observations and establish causality.