Fentanyl may not be necessary for adequate endoscopic moderate sedation

Table 1 Patient satisfaction and procedure quality measures in endoscopic procedures with midazolam alone vs midazolam plus fentanyl sedation

Characteristics	Midazolam	Midazolam/fentanyl	P value (or 95%CI)
n	148	152	-
Age (year), SD	52.3 (10.4)	52.3 (11.1)	1a
Male	59%	53%	0.3a
Upper endoscopy (EGD) (n)	15	17	0.9a
Colonoscopy (n)	122	119	0.4a
EGD/colonoscopy (n)	11	16	0.5a
Adverse events (n)	2d	1d	0.6b
Nausea (n)	1	1	1b
PROSAS discomfort score on a scale of 0 to 10, SD	0.30 (1.1)	0.29 (1.2)	(-0.24 to 0.27)c
PROSAS future sedation preference score on a scale of -5 to 5, SD	-0.09 (0.78)	-0.28 (0.94)	(0-0.39)c
Prep quality, Boston Bowel Prep score, SD	8.9 (0.64)	8.9 (0.39)	0.3a
Cecal intubation rate	100%	100%	1a
Cecal intubation time (minute), SD	7.99 (3.66)	6.97 (3.10)	0.02a
Withdrawal time (minute), SD	16.29 (4.34)	16.44 (4.01)	0.8a
Adenoma detection	36.7%	38.3%	1a
Sessile serrated polyp detection	8.9%	14.8%	0.3a
Midazolam dose (mg), SD	11.3 (3.8)	8.6 (3.1)	< 0.001a

^aP value for χ² test for the hypothesis that there is a difference in means.

^bP value based on Fisher’s exact test.

^c95% confidence interval for difference in scores between groups based on Welch’s 2-sample t-test for the null hypothesis test of midazolam being inferior with a non-inferiority margin of 1 point on the Procedural Sedation Assessment Survey question score. Results show non-inferiority since the 95% confidence interval resides in the non-inferiority zone.

^dAdverse events noted in the midazolam group consisted of 1 patient for whom the upper endoscopy was aborted due to agitation despite breaking protocol and administering fentanyl, and 1 patient with transient bradycardia and hypotension during a colonoscopy. Adverse events noted in the midazolam/fentanyl group consisted of 1 patient with a severe post procedure headache.

CI: Confidence interval; EGD: Upper endoscopy; PROSAS: Procedural Sedation Assessment Survey.