J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website https://www.jocmr.org

Original Article

Volume 13, Number 6, June 2021, pages 343-354

Use of Preoperative Single Dose Ivabradine for Perioperative Hemodynamic Stabilization During Non-Cardiac Elective Surgery Under General Anaesthesia: A Pilot Study

Figure 1. Variation of heart rate (beat/min) between the groups over time (intervention time: period of each event, namely, intubation [1], incision [2] and extubation [3]) using RMANOVA analysis (n = 25 each). Circle indicates the mean value; corresponding SD of each mean is as follow: ivabradine group: Time (1): ± 11.6, Time (2): ± 10.66, Time (3): ± 11.65; control group: Time (1): ± 12.9, Time (2): ± 11.68, Time (3): ± 8.55. Significance level between the groups: P < 0.005.

Figure 2. Variation of SBP (mm Hg) between the groups over time (intervention time: period of each event, namely, intubation [1], incision [2] and extubation [3]) using RMANOVA analysis (n = 25 each). Circle indicates the mean value. Corresponding SD of each mean is as follow: ivabradine group: Time (1): ± 14, Time (2): ± 12, Time (3): ± 20.331; control group: Time (1): ± 19, Time (2): ± 13, Time (3): ± 18.84. Significance level between the groups: P < 0.005. SBP: systolic blood pressure; SD: standard deviation.

Figure 3. Variation of DBP (mm Hg) between the groups over time (intervention time: period of each event, namely, intubation [1], incision [2] and extubation [3]) using RMANOVA analysis (n = 25 each). Circle indicates the mean value. Corresponding SD of each mean is as follow: ivabradine group: Time (1): ± 7.07, Time (2): ± 7.43, Time (3): ± 8.41; control group: Time (1): ± 11.7, Time (2): ± 9.50, Time (3): ± 10.699. Significance level between the groups: P < 0.005. DBP: diastolic blood pressure; SD: standard deviation.

Figure 4. Variation of MAP (mm Hg) between the groups over time (intervention time: period of each event, namely, intubation [1], incision [2] and extubation [3]) using RMANOVA analysis (n = 25 each). Circle indicates the mean value. Corresponding SD of each mean is as follow: ivabradine group: Time (1): ± 10.1, Time (2): ± 7.38, Time (3): ± 11.789; control group: Time (1): ± 13.4, Time (2): ± 10.2, Time (3): ± 13.84. Significance level between the groups: P < 0.005. MAP: mean arterial pressure; SD: standard deviation.

**Table 1.** Gender Distribution Among the Study Participants (N = 25 for Each Group)
	Group of patients	Total
Male
Count	5	7	12
Expected count	6.0	6.0	12.0
% within gender	41.7%	58.3%	100.0%
Female
Count	20	18	38
Expected count	19.0	19.0	38.0
% within gender	52.6%	47.4%	100.0%
Total
Count	25	25	50
Expected count	25.0	25.0	50.0
% within gender	50.0%	50.0%	100.0%

Table 1. Gender Distribution Among the Study Participants (N = 25 for Each Group)

Group of patients

Total

Ivabradine

Control

Male

Count

Expected count

6.0

12.0

% within gender

41.7%

58.3%

100.0%

Female

Count

Expected count

19.0

38.0

% within gender

52.6%

47.4%

100.0%

Total

Count

Expected count

25.0

50.0

% within gender

50.0%

100.0%

**Table 2.** Baseline Hemodynamic Parameters of the Study Participants (N = 25 Each)
Baseline	Group of patients	Test of significance (independent sample t-test)
SBP: systolic blood pressure; DBP: diastolic blood pressure; MAP: mean arterial pressure; SD: standard deviation.
Heart rate	83.40	10.24	82.24	12.44	0.360	0.720
SBP	128.60	15.27	124.32	13.33	1.056	0.296
DBP	81.00	8.93	80.12	6.23	0.404	0.688
MAP	96.87	10.00	94.85	7.63	0.800	0.428

Table 2. Baseline Hemodynamic Parameters of the Study Participants (N = 25 Each)

Baseline

Group of patients

Test of significance (independent sample t-test)

Ivabradine

Control

Mean

P value

SBP: systolic blood pressure; DBP: diastolic blood pressure; MAP: mean arterial pressure; SD: standard deviation.

Heart rate

83.40

10.24

82.24

12.44

0.360

0.720

SBP

128.60

15.27

124.32

13.33

1.056

0.296

DBP

81.00

8.93

80.12

6.23

0.404

0.688

MAP

96.87

10.00

94.85

7.63

0.800

0.428

**Table 3.** Change in Hemodynamic Parameters Beyond 20% of Baseline (N = 25 Each) During Intubation, Incision and Operation
	Group of patients
HR: heart rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; MAP: mean arterial pressure.
Change during intubation
Amount of change in HR
Decrease > 20%	0	0.0%	3	12.0%
Change within 20%	25	100.0%	20	80.0%
Increase > 20%	0	0.0%	2	8.0%
Amount of change in SBP
Decrease > 20%	2	8.0%	2	8.0%
Change within 20%	20	80.0%	20	80.0%
Increase > 20%	3	12.0%	3	12.0%
Amount of change in DBP
Decrease > 20%	3	12.00%	3	12.0%
Change within 20%	17	68.0%	18	72.0%
Increase > 20%	5	20.0%	4	16.0%
Amount of change in MAP
Decrease > 20%	3	12.0%	2	8.0%
Change within 20%	20	80.0%	19	76.0%
Change during incision and operation
Amount of change in HR
Decrease > 20%	4	16.0%	11	44.0%
Change < 20%	19	76.0%	10	40.0%
Increase > 20%	2	8.0%	4	16.0%
Amount of change in SBP
Decrease > 20%	6	24.0%	10	40.0%
Change < 20%	17	68.0%	14	56.0%
Increase > 20%	2	8.0%	1	4.0%
Amount of change in DBP
Decrease > 20%	7	28.0%	7	28.0%
Change < 20%	16	64.0%	14	56.0%
Increase > 20%	2	8.0%	4	16.0%
Amount of change in MAP
Decrease > 20%	9	36.0%	9	36.0%
Change < 20%	14	56.0%	15	60.0%
Increase > 20%	2	8.0%	1	4.0%

Table 3. Change in Hemodynamic Parameters Beyond 20% of Baseline (N = 25 Each) During Intubation, Incision and Operation

Group of patients

Ivabradine

Control

Count

HR: heart rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; MAP: mean arterial pressure.

Change during intubation

Amount of change in HR

Decrease > 20%

0.0%

12.0%

Change within 20%

100.0%

80.0%

Increase > 20%

0.0%

8.0%

Amount of change in SBP

Decrease > 20%

8.0%

Change within 20%

80.0%

Increase > 20%

12.0%

Amount of change in DBP

Decrease > 20%

12.00%

12.0%

Change within 20%

68.0%

72.0%

Increase > 20%

20.0%

16.0%

Amount of change in MAP

Decrease > 20%

12.0%

8.0%

Change within 20%

80.0%

76.0%

Change during incision and operation

Amount of change in HR

Decrease > 20%

16.0%

44.0%

Change < 20%

76.0%

40.0%

Increase > 20%

8.0%

16.0%

Amount of change in SBP

Decrease > 20%

24.0%

40.0%

Change < 20%

68.0%

56.0%

Increase > 20%

8.0%

4.0%

Amount of change in DBP

Decrease > 20%

28.0%

Change < 20%

64.0%

56.0%

Increase > 20%

8.0%

16.0%

Amount of change in MAP

Decrease > 20%

36.0%

Change < 20%

56.0%

60.0%

Increase > 20%

8.0%

4.0%

**Table 4.** Change in Hemodynamic Parameters Beyond 20% of Baseline (N = 25 Each) During Extubation
Change during extubation	Group of patients
HR: heart rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; MAP: mean arterial pressure.
Amount of change in HR
Decrease > 20%	0	0.0%	0	0.0%
Change < 20%	23	92.0%	22	88.0%
Increase > 20%	2	8.0%	3	12.0%
Amount of change in SBP
Decrease > 20%	1	4.0%	0	0.0%
Change < 20%	22	88.0%	21	84.0%
Increase > 20%	2	8.0%	4	16.0%
Amount of change in DBP
Decrease > 20%	0	0.0%	0	0.0%
Change < 20%	22	88.0%	21	84.0%
Increase > 20%	3	12.0%	4	16.0%
Amount of change in MAP
Decrease > 20%	1	4.0%	0	0.0%
Change < 20%	23	92.0%	20	80.0%
Increase > 20%	1	4.0%	5	20.0%

Table 4. Change in Hemodynamic Parameters Beyond 20% of Baseline (N = 25 Each) During Extubation

Change during extubation

Group of patients

Ivabradine

Control

Count

HR: heart rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; MAP: mean arterial pressure.

Amount of change in HR

Decrease > 20%

0.0%

Change < 20%

92.0%

88.0%

Increase > 20%

8.0%

12.0%

Amount of change in SBP

Decrease > 20%

4.0%

0.0%

Change < 20%

88.0%

84.0%

Increase > 20%

8.0%

16.0%

Amount of change in DBP

Decrease > 20%

0.0%

Change < 20%

88.0%

84.0%

Increase > 20%

12.0%

16.0%

Amount of change in MAP

Decrease > 20%

4.0%

0.0%

Change < 20%

92.0%

80.0%

Increase > 20%

4.0%

20.0%

**Table 5.** Comparison of Total Change in Hemodynamic Stability (From Baseline Till End of Observation Period of Extubation) Among the Study Groups (N = 25 Each)
Hemodynamic parameter	Group of patients	Independent sample t-test
SD: standard deviation.
Total change in heart rate from baseline, mean (SD)	6.00 (11.35)	-10.88 (16.45)	4.224	0.000
Total change in SBP from baseline, mean (SD)	-5.60 (18.58)	-8.96 (20.30)	0.610	0.544
Total change in DBP from baseline, mean (SD)	3.64 (12.61)	-1.32 (14.03)	1.315	0.195
Total change in MAP from baseline, mean (SD)	-5.21 (13.41)	-5.35 (15.92)	0.032	0.975

Table 5. Comparison of Total Change in Hemodynamic Stability (From Baseline Till End of Observation Period of Extubation) Among the Study Groups (N = 25 Each)

Hemodynamic parameter

Group of patients

Independent sample t-test

Ivabradine

Control

P value

SD: standard deviation.

Total change in heart rate from baseline, mean (SD)

6.00 (11.35)

-10.88 (16.45)

4.224

0.000

Total change in SBP from baseline, mean (SD)

-5.60 (18.58)

-8.96 (20.30)

0.610

0.544

Total change in DBP from baseline, mean (SD)

3.64 (12.61)

-1.32 (14.03)

1.315

0.195

Total change in MAP from baseline, mean (SD)

-5.21 (13.41)

-5.35 (15.92)

0.032

0.975

**Table 6.** Incidence of Bradycardia and Tachycardia Among the Study Participants (N = 25 Each)
	Group of patients	Total
Bradycardia
Count	1	0	1
Expected count	0.5	0.5	1.0
% within group	4.0%	0.0%	2.0%
Normal heart rate
Count	22	15	37
Expected count	18.5	18.5	37.0
% within group	88.0%	60.0%	74.0%
Tachycardia
Count	2	10	12
Expected count	6.0	6.0	12.0
% within group	8.0%	40.0%	24.0%
Total
Count	25	25	50
Expected count	25.0	25.0	50.0
% within group	100.0%	100.0%	100.0%

Table 6. Incidence of Bradycardia and Tachycardia Among the Study Participants (N = 25 Each)

Group of patients

Total

Ivabradine

Control

Bradycardia

Count

Expected count

0.5

1.0

% within group

4.0%

0.0%

2.0%

Normal heart rate

Count

Expected count

18.5

37.0

% within group

88.0%

60.0%

74.0%

Tachycardia

Count

Expected count

6.0

12.0

% within group

8.0%

40.0%

24.0%

Total

Count

Expected count

25.0

50.0

% within group

100.0%

**Table 7.** Incidence of Blood Pressure Among the Study Participants (N = 25 Each)
	Group of patients	Total
Normal
Count	19	20	39
Expected count	19.5	19.5	39.0
% within group	76.0%	80.0%	78.0%
Hypertension
Count	6	5	11
Expected count	5.5	5.5	11.0
% within group	24.0%	20.0%	22.0%
Total
Count	25	25	50
Expected count	25.0	25.0	50.0
% within group	100.0%	100.0%	100.0%

Table 7. Incidence of Blood Pressure Among the Study Participants (N = 25 Each)

Group of patients

Total

Ivabradine

Control

Normal

Count

Expected count

19.5

39.0

% within group

76.0%

80.0%

78.0%

Hypertension

Count

Expected count

5.5

11.0

% within group

24.0%

20.0%

22.0%

Total

Count

Expected count

25.0

50.0

% within group

100.0%