Comparison of the Safety and Efficacy of Remimazolam Besylate versus Dexmedetomidine for Patients Undergoing Fiberoptic Bronchoscopy: A Prospective, Randomized Controlled Trial

Figures & data

Table 1 Demographic Characteristics and Indication of FB Between the Two Groups

Variable	Group RA (n=60)	Group DA (n=60)	P-value
Age (years)	60.7±4.3	60.9±4.2	0.782
Sex (male/female)	40/20	41/19	0.845
History of smoking, n (%)	33 (55.0%)	38 (63.3%)	0.353
FEV1/FVC (%)	91.2±2.4	91.5±2.1	0.388
Height (cm)	166.9±4.7	166.1±4.7	0.373
Body weight (kg)	67.2±6.2	67.6±7.4	0.729
BMI (kg/m^2)	24.1±1.9	24.5±2.3	0.342
ASA I/II (n)	22/38	23/37	0.850
Comorbidity, n (%)			0.939
Hypertension	14 (23.3%)	15 (25.0%)
Diabetes	9 (15.0%)	11 (18.3%)
Coronary heart disease	10 (16.7%)	13 (21.7%)
Indication, n (%)			0.460
Lung cancer	22 (36.7%)	15 (25.0%)
Pneumonia	23 (38.3%)	31 (51.7%)
Pulmonary tuberculosis	7 (11.7%)	6 (10.0%)
Others	8 (13.3%)	8 (13.3%)
Procedure, n (%)			0.741
Endobronchial inspection	17 (28.3%)	16 (26.7%)
Bronchoscopic biopsy	25 (41.7%)	29 (48.3%)
Bronchoalveolar lavage	18 (30.0%)	15 (25.0%)

Note: Variables presented as mean ±SD or number of patients n (%).

Abbreviations: RA, remimazolam besylate combined with alfentanil; DA, dexmedetomidine combined with alfentanil; FEV1, Forced Expiratory Volume in the first second; FVC, Forced Vital Capacity; BMI, Body Mass Index; ASA, American Society of Anesthesiology.

Figure 1 Patient flowchart with CONSORT guidelines.

Table 2 The Safety Outcomes Between the Two Groups

Variable, n (%)	Group RA (n=60)	Group DA (n=60)	P-value
Lowest oxygen saturation	89.2±2.5	84.9±2.6*	0.001
Incidence of intraoperative awareness	6 (41.3%)	8 (37.0%)	0.570
Hypotension	13 (10.9%)	6 (26.1%)	0.080
Hypertension	3 (8.7%)	2 (8.7%)	1.000
Bradycardia	5 (6.5%)	13 (10.9%)*	0.041
Hypoxia	10 (19.6%)	16 (26.1%)	0.184
Tachycardia	6 (8.7%)	3 (10.9%)	0.491

Notes: Variables presented as mean ±SD or number of patients n (%). *P < 0.05 vs Group RA.

Abbreviations: RA, remimazolam besylate combined with alfentanil; DA, dexmedetomidine combined with alfentanil.

Figure 2 Hemodynamic measurements. Compared with patients in the DA group, S_PO₂, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were significantly decreased at T2 and T3 in the RA group. Similarly, heart rate (HR) was significantly increased from T2 to T4 in the DA group. Time points are as follows: T0: arrival at bronchoscopy room, T1: immediately before start of FB, T2: immediately after entering the glottis, T3: 5 min after entering the glottis, T4: 10 min after entering the glottis, T5: end of FB, T6: 5 min after FB, T7: leaving the recovery room. *P < 0.05 vs RA group.

Abbreviations: RA, remimazolam besylate combined with alfentanil; DA, dexmedetomidine combined with alfentanil.

Table 3 The Efficacy Outcomes Between the Two Groups

Variable	Group RA (n=60)	Group DA (n=60)	P-value
Procedure success, n (%)	55 (91.7%)	52 (86.7%)	0.378
Time metrics
Induction time (min)	6.6±1.9	9.0±1.2*	0.001
Procedure time (min)	22.0±3.1	22.3±3.5	0.619
Time to fully alert (min)	4.4±1.3	7.0±1.5*	0.001
Time to leaving the recovery room (min)	11.8±1.6	16.6±2.3*	0.001
Scores of bronchoscopy feasibility
T2	5.0 (5.0–6.0)	7.0 (6.0–8.0)*	0.001
T3	5.0 (4.0–6.0)	5.0 (4.3–6.0)	0.369
Consumption of alfentanil (µg)	671.7±62.7	676.0±73.7	0.729
Consumption of remimazolam besylate (mg)	69.2±14.1	–
Consumption of dexmedetomidine (µg)	–	45.0±6.5
Number of remedies, n (%)	9 (15.0%)	13 (21.7%)	0.345
Patient satisfaction scores	5.0 (4.0–5.0)	4.0 (4.0–5.0)	0.111
Bronchoscopist satisfaction scores	4.0 (4.0–5.0)	4.0 (4.0–5.0)	0.628
Willing to the repeat FB, n (%)	53 (88.3%)	51 (85.0%)	0.591

Notes: Variables presented as mean ±SD, median (interquartile range), or number of patients n (%). T2: immediately after entering the glottis, T3: 5 min after entering the glottis. *P < 0.05 vs Group RA.

Abbreviations: RA, remimazolam besylate combined with alfentanil; DA, dexmedetomidine combined with alfentanil; FB, flexible bronchoscopy.