1 Introduction
2 Methods
2.1 Study Population
2.2 Study Design
2.3 Maintenance Period of Up to 6 h
2.4 Concomitant Drugs and Therapies
2.5 Clinical Measurements
2.6 Endpoints
2.7 Safety Variables
2.8 Statistical Analysis
3 Results
3.1 Patient Characteristics
Variable | Final dose | Total (n = 88) | |||
---|---|---|---|---|---|
LL dose (n = 10) | L dose (n = 15) | M dose (n = 27) | H dose (n = 36) | ||
Sex | |||||
Male | 7 (70.0) | 11 (73.3) | 16 (59.3) | 28 (77.8) | 62 (70.5) |
Female | 3 (30.0) | 4 (26.7) | 11 (40.7) | 8 (22.2) | 26 (29.5) |
Age (years) | 64.6 ± 7.6 (54–75) | 59.8 ± 14.1 (23–75) | 56.0 ± 16.6 (21–77) | 61.7 ± 12.8 (29–79) | 60.0 ± 14.0 (21–79) |
Type of supraventricular tachyarrhythmiasa
| |||||
Paroxysmal supraventricular tachycardia | 1 (10.0) | 0 (0.0) | 1 (3.7) | 1 (2.8) | 3 (3.4) |
Paroxysmal atrial fibrillation | 5 (50.0) | 6 (40.0) | 5 (18.5) | 10 (27.8) | 26 (29.5) |
Paroxysmal atrial flutter | 0 (0.0) | 0 (0.0) | 4 (14.8) | 2 (5.6) | 6 (6.8) |
Sinus tachycardia | 4 (40.0) | 9 (60.0) | 18 (66.7) | 23 (63.9) | 54 (61.4) |
Site of surgery | |||||
Craniotomy | 1 (10.0) | 1 (6.7) | 4 (14.8) | 2 (5.6) | 8 (9.1) |
Open-heart surgery | 0 (0.0) | 3 (20.0) | 5 (18.5) | 6 (16.7) | 14 (15.9) |
Resection of esophageal cancer | 4 (40.0) | 4 (26.7) | 5 (18.5) | 11 (30.6) | 24 (27.3) |
Upper and lower abdominal surgery | 3 (30.0) | 2 (13.3) | 4 (14.8) | 6 (16.7) | 15 (17.0) |
Thoracotomy | 1 (10.0) | 4 (26.7) | 3 (11.1) | 2 (5.6) | 10 (11.4) |
Others | 1 (10.0) | 1 (6.7) | 6 (22.2) | 9 (25.0) | 17 (19.3) |
Admission to ICU (days) | 2.3 ± 1.3 | 2.5 ± 1.7 | 3.4 ± 2.5 | 4.2 ± 3.7 | 3.5 ± 2.9 |
HR (beats/min) | 131.1 ± 19.9 (107–174) | 130.4 ± 9.2 (115–144) | 129.0 ± 11.5 (106–152) | 127.9 ± 12.1 (109–166) | 129.0 ± 12.4 (106–174) |
SBP (mmHg) | 119.5 ± 30.3 (71–161) | 133.3 ± 28.1 (101–186) | 134.4 ± 31.2 (97–239) | 133.1 ± 28.1 (82–187) | 131.9 ± 29.2 (71–239) |
DBP (mmHg) | 66.9 ± 11.5 (53–86) | 73.6 ± 16.7 (50–108) | 68.9 ± 15.3 (48–108) | 70.2 ± 13.2 (48–100) | 69.9 ± 14.1 (48–108) |
3.2 Efficacy
3.2.1 Bradycardic Effects
3.2.2 Heart Rate and Blood Pressure Changes by Dose
Parameter | Regimen | Valuea
| Differenceb
|
P-value (paired t test) | |
---|---|---|---|---|---|
Pre-dose | Post-dose | ||||
HR (beats/min) | LL (n = 82) | 128.4 ± 12.4 | 115.5 ± 15.2 | −10.0 ± 9.4 | 0.0001 |
L (n = 71) | 128.4 ± 11.1 | 110.5 ± 15.0 | −13.9 ± 9.3 | 0.0001 | |
M (n = 52) | 127.5 ± 10.7 | 104.1 ± 15.1 | −18.3 ± 9.9 | 0.0001 | |
H (n = 29) | 127.6 ± 11.9 | 100.5 ± 8.6 | −20.9 ± 6.7 | 0.0001 | |
SBP (mmHg) | LL (n = 80) | 132.9 ± 29.2 | 124.9 ± 24.5 | −8.0 ± 15.1 | 0.0001 |
L (n = 69) | 135.5 ± 28.5 | 123.6 ± 24.7 | −11.9 ± 18.0 | 0.0001 | |
M (n = 52) | 135.6 ± 30.1 | 122.1 ± 25.9 | −13.4 ± 16.1 | 0.0001 | |
H (n = 29) | 132.7 ± 28.9 | 120.6 ± 26.8 | −12.2 ± 14.4 | 0.0001 | |
DBP (mmHg) | LL (n = 80) | 70.5 ± 14.2 | 67.7 ± 13.5 | −2.8 ± 7.1 | 0.0008 |
L (n = 69) | 71.3 ± 14.7 | 67.1 ± 13.8 | −4.1 ± 8.9 | 0.0002 | |
M (n = 52) | 70.8 ± 14.9 | 65.9 ± 13.9 | −4.8 ± 7.7 | 0.0001 | |
H (n = 29) | 70.7 ± 14.1 | 64.1 ± 13.9 | −6.6 ± 10.7 | 0.0024 |