A comparative study of clonidine and magnesium sulfate premedication on perioperative hormonal stress responses, hemodynamic stability and postoperative analgesia in patients with gallbladder diseases undergoing laparoscopic cholecystectomy. A randomized, double-blind, controlled study

Figures & data

Figure 1. Participant flow chart.

Table 1. Demographic characteristics of the three studied groups(Mean ± SD)

Demographic profile	Group C (n = 35)	Group M (n = 35)	Group S (n = 35)	P.Value
Age(years)	33.3 ± 11.8	32.9 ± 12.3	31.7 ± 12.3	0.795
Sex(F:M)	32:3	33:2	34:1	0.875
Weight(kg)	68.7 ± 7.3	69.3 ± 8.2	70.1 ± 8.6	0.742
ASA Grade(I:II)	17:3	18:2	17:3	0.864
Duration of surgery(minutes)	57.8 ± 7.4	56.9 ± 7.9	58.3 ± 8.1	0.693

F:M = Female:Male ratio.

ASA = American Society Of Anesthesiologists

Data are represented as either mean ± SD or by absolute numbers.

No significant differences regarding demographic profile amongst the studied three groups (P > 0.05).

Figure 2. Heart rate changes in the studied three groups.

P0, P15, P30 = before pneumoperitoneum and 15, 30 minutes after pneumoperitoneum.Group C = Clonidine group, Group M = Magnesium sulfate group,Group S = Placebo(saline)group.Values are in mean ± SD.Bpm = beat per minute.

Figure 3. Mean arterial blood pressure (MBP) changes in the studied three groups.

P0, P15, P30 = before pneumo-peritoneum and 15, 30 minutes after pneumo-peritoneum.Group C = Clonidine group, Group M = Magnesium sulfate group, Group S = Placebo(saline)group.Values are in mean ± SD.MBP = Mean blood pressure.

Table 2. Plasma cortisol (ug /dl) level during different time intervals in the studied three groups

	Group C (n = 35)	Group M (n = 35)	Group S (n = 35)	P.Value
30 min. preoperative:(I0)	5.36 ± 0.43	6.13 ± 1.06	5.74 ± 0.86	0.764^NS
3 min .after endotracheal intubation:(I1)	6.56 ± 1.11	7.48 ± 1.25	13.8 ± 3.27***	<0.001
15 min. after pneumo- peritoneum: (I2)	9.85 ± 2.87	10.49 ± 2.92	23.4 ± 4.9***	<0.001
5 min. after exsufflation (I3)	9.13 ± 2.63	9.78 ± 2.54	21.16 ± 4.3***	<0.001
6 hours after extubation:(I4)	8.85 ± 2.75	9.13 ± 2.79	14.38 ± 3.9*	<0.05
First postoperative day:(I5)	8.32 ± 2.12	8.86 ± 2.8	9.56 ± 3.7	0.628^NS

Values are in mean ±SD

There was a highly statistically significant increase in the level of cortisol in the control group compared to the two studied groups at I_1,I₂ and I₃ (P < 0.001) then there was a statistically significant increase in cortisol level in the control group compared to the two studied groups at 6 hours after extubation(I₄) (P < 0.05) but there was no statistically significant differences between the three studied groups at first postoperative day(I₅) (P > 0.05).

*** = highly statistically significant.

* = statistically significant.

NS = non-significant.

Table 3. Intra- operative conditions and recovery characteristics in the studied three groups

	Group C(n = 35)	Group M(n = 35)	Group S(n = 35)	P value
Mean intra-abdominal pressure(mm.Hg):	12.74 ± 0.42	12.82 ± 0.45	12.90 ± 0.43	0.865 (NS)
Mean duration of pneumoperitoneum(min.):	34.86 ± 3.25	32.96 ± 2.94	33.42 ± 3.04	0.421 (NS)
Intraoperative requirement of propofol[maintainance](mg/kg/hour):	1.25 ± 0.25	1.74 ± 0.45	4.37 ± 1.45*	<0.05(S)
Extubation time:(BIS>80)	6.8 ± 1.7	9.9 ± 2.9*	7.4 ± 2.1	<0.01(S)
Response to verbal commands:	9.2 ± 1.7	12.8 ± 2.1*	9.1 ± 1.7	<0.01(S)

Values are presented as mean ± S.D

NS = non- significant

S = significant

Table 4. Postoperative adverse events in the studied three groups

Variable:	Group C(n = 35)	Group M(n = 35	Group S(n = 35)	P.value
1-shivering:	0	0	2(5.7%)	0.452^NS
2-PONV:	0	0	1(2.85%)	0.825^NS
3-post-operative agitation:	0	0	2(5.7%)	0.452^NS
3-post-operative sedation score(≥2):	2(5.7%)	0	0	0.452^NS

-Values are expressed as number(%).

-NS = non- significant.

Table 5. Post-operative analgesic consumption in the three studied groups

Variable	Group C	Group M	Group S	P. value
−24 hours post-operative rescue analgesia: .Ketorolac(mg): .Tramadol(mg):	24.3 ± 9.7 32.4 ± 7.2	25.2 ± 10.1 25.7 ± 6.9	78.8 ± 15.6*** 95.6 ± 15.4***	<0.001 <0.001
-Onset of first post-operative rescue analgesia(hour):	4.9 ± 1.5	5.2 ± 1.6	1.7 ± 1.1***	<0.001

-Data are presented as mean ±SD

-P = the comparison among the three groups.

-*** = highly statistically significant (p < 0.001).