Propofol vs midazolam plus fentanyl for upper gastrointestinal endomicroscopy: A randomized trial

Table 1 Clinical characteristics of patients

Patient characteristics	P group	M/F group	P value
Patients, n	49	51
Gender (male/female), n	24/25	23/28	NS
Mean age, yr (range)	53 (27-77)	55 (32-78)	NS
Body weight, kg (mean ± SD)	64.14 ± 10.21	63.84 ± 9.48	NS
Habit, cases (n)
Alcohol consumption			NS
Daily drinker	8	5
Social drinker	10	5
None-drinker	31	41
Tobacco			NS
≥ 1 PD	5	5
< 1 PD	3	5
Quit smoking	4	1
None-smoker	37	40
ASA I	34	37	NS
ASA II	15	14	NS

NS: Not significant; PD: Pack-day; ASA: American Society of Anesthesiologists; P group: Propofol group; M/F group: Midazolam plus fentanyl group.

Table 2 Proportion of good-quality endomicroscopic images of each examined area %

	P group	M/F group	P value
Duodenal bulb	72.17 (760/1053)	50.22 (577/1149)	< 0.001
Lesser curvature of antrum	66.44 (778/1171)	45.73 (562/1229)	< 0.001
Greater curvature of antrum	80.49 (916/1138)	64.99 (776/1194)	< 0.001
Incisura angularis	83.72 (581/694)	50.17 (438/873)	< 0.001
Lesser curvature of gastric body	71.41 (602/843)	48.07 (448/932)	< 0.001
Greater curvature of gastric body	81.85 (857/1047)	66.46 (757/1139)	< 0.001
Fundus	67.39 (217/322)	46.00 (236/513)	< 0.001
Cardia	71.83 (2068/2879)	49.84 (1395/2799)	< 0.001
Esophagus	67.94 (284/418)	56.04 (297/530)	< 0.001
Lesions	67.28 (1285/1910)	52.53 (1161/2210)	< 0.001
Total	72.75 (8348/11475)	52.89 (6647/12568)	< 0.001

P group: Propofol group; M/F group: Midazolam plus fentanyl group.

Table 3 Characteristics of endoscopic lesions in the two groups

	P group	M/F group	P value
Number of lesions	36	38	NS
Locations			NS
Duodenum	1	2
Antrum	15	14
Incisure angularis	9	6
Gastric body/fundus	3	3
Cardia	3	5
Esophagus	5	8
Histopathology			NS
Inflammation	22	21
Intestinal metaplasia	10	10
Neoplasia	4	7

NS: Not significant; P group: Propofol group; M/F group: Midazolam plus fentanyl group.

Table 4 Diagnostic capacity of integrated confocal laser endomicroscopy for endoscopic mucosal lesions of the upper gastrointestinal tract (95% CI)

	Inflammation			Intestinal metaplasia			Neoplasia
	P group	M/F group	P value	P group	M/F group	P value	P group	M/F group	P value
Sensitivity (%)	90.48 (71.09-97.35)	89.47 (68.61-97.06)	NS	90.00 (59.58-98.21)	80.00 (49.02-94.33)	NS	100(51.01-1)	85.71 (48.69-97.43)	NS
Specificity (%)	92.86 (68.53-98.73)	94.12 (73.02-98.95)	NS	96.00 (80.46-99.29)	95.65 (79.01-99.23)	NS	96.77 (83.81-99.43)	89.66 (73.61-96.42)	NS
PLR	12.67	15.21	NS	22.50	18.40	NS	31	8.29	0.015
NLR	0.10	0.11	NS	0.10	0.21	0.014	0	0.16	< 0.001

PLR: Positive likelihood ratio; NLR: Negative likelihood ratio; NS: Not significant; P group: Propofol group; M/F group: Midazolam plus fentanyl group.

Table 5 Quality of sedation

	P group	M/F group	P value
Sedation time (min)	3.22 ± 1.70	4.47 ± 2.40	0.002
Procedure time (min)	25.00 ± 6.51	28.45 ± 8.04	0.028
Adverse events			0.339
Hypoxemia	0	0
Hypotension	3	1
Bradycardia	0	0
Patient assessment
Satisfaction	10 (10–10)	10 (9–10)	0.105
Pain or discomfort	0 (0–0)	0 (0–1)	0.145
Intraprocedural recall	0 (0–0)	0 (0–1)	0.006
Willingness to repeat (n)			0.559
Lighter	5	4
Deeper	4	7
Same level	40	40
Endoscopist assessment
Satisfaction with sedation	10 (9–10)	9 (8–10)	0.003
Patient cooperation	4 (4–4)	4 (3–4)	0.002
Quality of endoscopy	4 (4–4)	4 (3–4)	0.018
Level of sedation			0.014
Apparently inadequate	0	3
Inadequate	7	16
Adequate	41	31
Oversedated	1	1
Assistant satisfaction	9 (9–10)	8 (7–10)	0.001
Anesthetist satisfaction	9 (9–10)	7 (5–8)	< 0.001

Continuous variables were given as the mean ± SD. Non-normally distributed variables were expressed as median (the 1st-3rd interquartile) and compared with the Mann-Whitney U test. P group: Propofol group; M/F group: Midazolam plus fentanyl group.