Hyoscine butyl-bromide versus ondansetron for nausea and vomiting during caesarean delivery under spinal anaesthesia. A randomized clinical trial

Figures & data

Figure 1. CONSORT flowchart showing patient recruitment.

Table 1. Patient’s demographic and clinical data among the three groups.

	Group H (n = 55)	Group O (n = 55)	Group C (n = 55)	P value
Age (years)	27.04 ± 5.17	26.53 ± 5.32	26.82 ± 4.97	0.87
Weight (kg)	70.62 ± 8.18	73.38 ± 9.89	74.07 ± 13.61	0.21
Height (cm)	158.8 ± 3.57	160.24 ± 3.49	158.84 ± 3.67	0.06
BMI (kg/m^2)	28.55 ± 3.52	27.96 ± 2.74	29.31 ± 5.02	0.19
Gestational age (weeks)	37.76 ± 0.94	37.8 ± 0.89	37.67 ± 1.07	0.78
Sensory level at 15 min (dermatome)	T3 (T2 – T4)	T3 (T2 – T4)	T3 (T3 – T5)	0.81

Data are presented as mean±SD, median (25-75th percentiles). BMI = Body mass index.

Table 2. Intraoperative complication measurements among the three groups.

	Group H (n = 55)	Group O (n = 55)	Group C (n = 55)	P-value	Effect size^! (95% CI)
Nausea n (%)	23(42)	16(29)	27(49)	PHC = 0.44 POC = 0.03	0.7 (0.35, 1.6) 0.4 (0.19, 0.93)
All emesis n (%)	14(25)	11(20)	24(44)	PHC = 0.046 POC = 0.009	0.4 (0.19, 0.98) 0.3 (0.14, 0.75)
IONV n (%)	24(44)	17(31)	28(51)	PHC = 0.46 POC = 0.034	0.7 (0.35, 1.58) 0.4 (0.19, 0.94)
Bradycardia n (%)	1(1.8)	4(7.3)	8(14.5)	PHC = 0.039 POC = 0.196	0.1 (0.01, 0.90) 0.2 (0.02, 2.14)
Hypotension n (%)	28(51)	22(40)	34(62)	PHC = 0.25 POC = 0.023	0.6 (0.30, 1.37) 0.4 (0.19, 0.89)
Intraoperative chest pain n (%)	1(1.8)	0 (0%)	0 (0%)	NS	-
Intra. & Postoperative Confusion N (%)	0 (0%)	0 (0%)	0 (0%)	NS	-

^!Odds ratios are reported for binary variables. IONV = Intraoperative nausea and vomiting.

P_HC = P-value comparing Group Metoclopramide (H) vs Group Placebo (C).

P_OC = P-value comparing Group Ondansetron (O) vs Group Placebo (C). NS = Non-Significant. p value < 0.05 is considered significant.

Table 3. APGAR score among the three groups.

	Group H (n = 55)	Group O (n = 55)	Group C (n = 55)	P value
	Mean (SD)	Mean (SD)	Mean (SD)
1 min	6.91 (1.54)	7.04 (1.54)	6.82 (1.57)	0.760
5 min	8.75 (0.78)	8.69 (0.81)	8.75 (0.84)	0.921

*Significant as p value < 0.05.

Table 4. Postoperative nausea and vomiting among the three groups over the first 24 h.

	Group H (n = 55)	Group O (n = 55)	Group C (n = 55)	P-value	Effect size^! (95% CI)
Nausea n (%)	24(44)	11(20)	29(53)	PHC = 0.341 POC <0.001	0.7 (0.3, 1.5) 0.2 (0.1, 0.5)
All emesis n (%)	25(45)	9(16)	29(53)	PHC = 0.45 POC <0.001	0.7 (0.3, 1.6) 0.2 (0.07, 0.4)
PONV n (%)	28(51)	12(22)	31(56)	PHC = 0.57 POC <0.001	0.8 (0.4, 1.7) 0.2 (0.1, 0.5)

^!Odds ratios are reported for binary variables. PONV = postoperative nausea and vomiting.

P_HC = P-value comparing Group Metoclopramide (H) vs Group Placebo (C).

P_OC = P-value comparing Group Ondansetron (O) vs Group Placebo (C). NS = non-Significant. p value < 0.05 is considered significant.