Clinical and economic burden of procedural sedation-related adverse events and their outcomes: analysis from five countries

Figures & data

Table 1 Demographics and select procedural sedation parameters of survey respondents

Item	Global	France	Germany	Italy	UK	US
n	101 (100.0%)	20 (100.0%)	20 (100.0%)	20 (100.0%)	20 (100.0%)	21 (100.0%)
Medical practice
Sedation nurse	47 (46.5%)	9 (45.0%)	11 (55.0%)	7 (35.0%)	10 (50.0%)	10 (47.6%)
Anesthesiologist	31 (30.7%)	10 (50.0%)	5 (25.0%)	5 (25.0%)	5 (25.0%)	6 (28.6%)
Gastroenterologist	16 (15.8%)	0 (0.0%)	3 (15.0%)	8 (40.0%)	3 (15.0%)	2 (9.5%)
Cardiologist	3 (3.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (5.0%)	2 (9.5%)
Critical care specialist	3 (3.0%)	1 (5.0%)	1 (5.0%)	0 (0.0%)	1 (5.0%)	0 (0.0%)
Plastic surgeon	1 (1.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (4.8%)
Associated setting
General hospital	52 (51.5%)	9 (45.0%)	14 (70.0%)	7 (35.0%)	12 (60.0%)	10 (47.6%)
University hospital	36 (35.6%)	9 (45.0%)	5 (25.0%)	8 (40.0%)	9 (45.0%)	5 (23.8%)
Private hospital	16 (15.8%)	0 (0.0%)	1 (5.0%)	6 (30.0%)	3 (15.0%)	6 (28.6%)
Private clinic	11 (10.9%)	3 (15.0%)	0 (0.0%)	3 (15.0%)	0 (0.0%)	5 (23.8%)
Physician’s office	5 (5.0%)	1 (5.0%)	0 (0.0%)	1 (5.0%)	0 (0.0%)	3 (14.3%)
Hospital outpatient clinic	4 (4.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	4 (19.0%)
Ambulatory surgical center	2 (2.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (9.5%)
Years of experience
5+	8 (7.9%)	3 (15.0%)	0 (0.0%)	1 (5.0%)	3 (15.0%)	1 (4.8%)
2–5	93 (92.1%)	17 (85.0%)	20 (100.0%)	19 (95.0%)	17 (85.0%)	20 (95.2%)
Procedures per month
20–50	54 (53.5%)	10 (50.0%)	9 (45.0%)	10 (50.0%)	15 (75.0%)	10 (47.6%)
50+	47 (46.5%)	10 (50.0%)	11 (55.0%)	10 (50.0%)	5 (25.0%)	11 (52.4%)
Sedation agents used
Midazolam	93 (92.1%)	16 (80.0%)	17 (85.0%)	20 (100.0%)	20 (100.0%)	20 (95.2%)
Propofol	90 (89.1%)	19 (95.0%)	20 (100.0%)	18 (90.0%)	15 (75.0%)	18 (85.7%)
Fentanyl	75 (74.3%)	9 (45.0%)	16 (80.0%)	18 (90.0%)	18 (90.0%)	14 (66.7%)
Ketamine	56 (55.4%)	18 (90.0%)	10 (50.0%)	7 (35.0%)	9 (45.0%)	12 (57.1%)
Meperidine	15 (14.9%)	1 (5.0%)	2 (10.0%)	6 (30.0%)	4 (20.0%)	2 (9.5%)
Monitoring methods used
Pulse oximetry	99 (98.0%)	19 (95.0%)	20 (100.0%)	20 (100.0%)	19 (95.0%)	21 (100.0%)
Heart rate	97 (96.0%)	18 (90.0%)	20 (100.0%)	19 (95.0%)	19 (95.0%)	21 (100.0%)
Blood pressure	95 (94.1%)	18 (90.0%)	20 (100.0%)	16 (80.0%)	20 (100.0%)	21 (100.0%)
ECG	91 (90.1%)	15 (75.0%)	20 (100.0%)	18 (90.0%)	17 (85.0%)	21 (100.0%)
Respiratory rate	82 (81.2%)	16 (80.0%)	15 (75.0%)	12 (60.0%)	18 (90.0%)	21 (100.0%)
Capnography	62 (61.4%)	11 (55.0%)	14 (70.0%)	8 (40.0%)	13 (65.0%)	16 (76.2%)
Source of guidelines used
Local	70 (69.3%)	12 (60.0%)	17 (85.0%)	10 (50.0%)	14 (70.0%)	17 (81.0%)
National	57 (56.4%)	12 (60.0%)	11 (55.0%)	10 (50.0%)	11 (55.0%)	13 (61.9%)
Professional society	43 (42.6%)	10 (50.0%)	13 (65.0%)	4 (20.0%)	4 (20.0%)	12 (57.1%)
International	17 (16.8%)	5 (25.0%)	3 (15.0%)	6 (30.0%)	2 (10.0%)	1 (4.8%)

Note: Numbers in parentheses indicate percentages globally or by country.

Abbreviation: ECG, electrocardiography.

Table 2 Reported procedural sedation costs

Type of procedural sedation	France (EUR)	Germany (EUR)	Italy (EUR)	UK (GBP)	US (USD)
Cost of uncomplicated procedure	550 (300–1,000)	74 (0–150)	263 (0–800)	570 (0–1,500)	2,030 (150–5,000)
Cost with sedation-related complication	857 (390–1,500)	132 (0–300)	294 (0–880)	758 (0–2,250)	3,200 (600–6,250)
Estimated costs of complications	258 (90–500)	57 (0–150)	31 (0–80)	188 (0–750)	1,170 (400–2,500)

Notes: Payers were asked to provide costs for uncomplicated sedation procedures (“fully loaded” costs, inclusive of administration, management, quality, and legal and transport services) and individual costs of procedures with complications. The cost differences due to complications were calculated, and mean values and ranges were determined. All values are mean values with range in parentheses.

Table 3 Global AEs and treatment patterns

AE/treatment	Rank	No intervention (%)	AW repositioning (%)	Additional sedative (%)	Antihistamine (%)	Atropine (%)	Bag mask (%)	Call anesthesiologist (%)	Chest compression (%)	Code blue (%)
Hypotension	1	36.1 (27.9–44.7)	0.3 (0.0–3.3)	0.1 (0.0–0.5)	0.1 (0.0–0.6)	2.6 (1.5–4.0)	0.3 (0.0–1.0)	2.8 (0.9–8.2)	0.0 (0.0–0.0)	0.2 (0.1–0.4)
Bradycardia	2	57.7 (44.3–67.8)	0.7 (0.3–1.7)	1.0 (0.3–2.1)	0.4 (0.2–0.8)	19.5 (14.3–25.4)	3.1 (0.5–6.6)	3.2 (1.7–5.3)	0.0 (0.0–0.1)	0.3 (0.0–1.0)
Tachycardia	3	37.5 (23.7–53.9)	0.2 (0.0–0.9)	31.6 (18.4–51.0)	0.4 (0.0–1.0)	0.0 (0.0–0.2)	0.0 (0.0–0.5)	9.2 (3.1–22.6)	0.0 (0.0–0.1)	0.0 (0.0–0.5)
Oxygen desaturation (mild, short)	4	20.8 (6.2–35.5)	9.4 (5.1–42.2)	1.5 (0.8–2.5)	0.9 (0.4–2.4)	0.8 (0.2–1.7)	12.0 (7.8–20.3)	8.4 (2.3–14.9)	0.0 (0.0–0.0)	0.5 (0.1–1.6)
Hypertension	5	38.3 (26.7–48.8)	0.4 (0.0–1.9)	35.4 (20.8–47.1)	0.1 (0.0–0.4)	0.0 (0.0–0.0)	0.1 (0.0–0.5)	3.9 (1.7–10.6)	0.0 (0.0–0.0)	0.0 (0.0–0.0)
Apnea (not prolonged)	6	22.9 (13.5–36.3)	16.1 (7.8–31.9)	1.2 (0.2–3.0)	0.2 (0.0–0.7)	0.6 (0.2–1.9)	19.9 (11.6–30.3)	8.8 (1.5–24.5)	0.0 (0.0–0.1)	0.4 (0.1–1.3)
Oxygen desaturation (mild, long)	7	31.3 (21.2–49.2)	16.2 (9.7–35.3)	0.5 (0.2–1.9)	0.0 (0.0–0.2)	0.2 (0.0–0.7)	12.2 (7.1–23.4)	11.5 (2.3–23.4)	0.0 (0.0–0.1)	0.2 (0.1–0.4)
AW obstruction	8	22.3 (7.9–40.9)	29.8 (5.1–65.3)	0.8 (0.0–2.7)	0.0 (0.0–0.5)	0.0 (0.0–0.7)	5.0 (2.1–17.5)	4.2 (1.6–12.4)	0.0 (0.0–0.0)	3.5 (0.0–9.0)
Failed sedation	9	5.4 (0.0–36.2)	1.4 (0.0–3.8)	54.1 (25.2–78.2)	0.0 (0.0–0.0)	0.0 (0.0–0.8)	0.4 (0.0–7.5)	4.8 (0.0–15.7)	0.0 (0.0–0.3)	0.0 (0.0–0.0)
Apnea (long)	10	16.8 (7.3–46.9)	32.4 (18.2–45.9)	0.0 (0.0–0.0)	0.0 (0.0–0.2)	0.0 (0.0–1.7)	31.7 (18.1–46.7)	23.3 (13.3–33.1)	0.1 (0.0–1.0)	0.9 (0.2–6.2)
Allergy	11	4.8 (1.1–12.6)	1.7 (0.0–6.4)	0.0 (0.0–1.5)	19.3 (7.3–64.6)	0.0 (0.0–1.6)	11.9 (0.0–36.4)	5.9 (1.2–19.6)	0.0 (0.0–0.0)	0.0 (0.0–1.4)
Oxygen desaturation (severe)	12	9.9 (3.5–22.4)	27.6 (12.2–48.8)	0.3 (0.0–1.6)	0.1 (0.0–0.3)	0.2 (0.0–0.5)	26.9 (18.5–38.2)	19.2 (8.0–37.4)	0.6 (0.0–1.3)	1.9 (0.7–5.6)
Cardiovascular collapse	13	6.4 (0.6–32.5)	3.5 (1.4–6.7)	0.0 (0.0–0.8)	0.0 (0.0–1.9)	9.0 (4.8–19.4)	22.0 (6.6–37.1)	45.7 (26.2–62.7)	17.1 (0.6–36.6)	9.0 (3.7–25.0)
Cardiac arrest	14	2.6 (0.5–30.5)	9.3 (4.8–35.9)	0.3 (0.0–0.8)	0.6 (0.0–1.6)	29.2 (10.5–45.3)	43.1 (19.3–60.1)	68.0 (46.8–81.7)	51.4 (35.1–72.3)	43.8 (22.7–71.8)
Seizure	15	5.8 (0.0–23.4)	13.4 (3.0–27)	36.4 (14.0–62.0)	0.0 (0.0–0.6)	0.0 (0.0–0.3)	19.4 (5.9–66.7)	5.8 (0.0–34.4)	0.0 (0.0–0.0)	3.4 (0.0–6.1)
AE/treatment	Rank	IV fluid (%)	Laryngeal mask AW (%)	Oral/nasal AW (%)	Positive AW pressure (%)	Resolution time (min)	Reversal agent (%)	Supplemental oxygen (%)	Tactile stimulation (%)	Tracheal intubation (%)
Hypotension	1	38.6 (29.2–51.0)	0.4 (0.1–1.0)	0.7 (0.1–1.3)	0.0 (0.0–0.0)	3.9 (3.2–7.2)	3.9 (1.1–8.5)	18.2 (8.9–28.7)	5.0 (2.0–10.0)	0.0 (0.0–0.1)
Bradycardia	2	7.0 (3.6–10.9)	0.8 (0.2–2.5)	1.5 (0.4–3.3)	0.1 (0.0–0.5)	2.2 (1.8–3.2)	1.4 (0.7–2.6)	7.4 (4.2–13.9)	2.1 (0.8–3.7)	0.1 (0.0–0.4)
Tachycardia	3	10.4 (3.8–22.3)	0.0 (0.0–0.4)	0.6 (0.0–2.4)	0.0 (0.0–0.2)	4.8 (4.0–5.7)	1.1 (0.4–2.7)	21.7 (4.9–47.6)	0.1 (0.0–0.7)	0.0 (0.0–0.2)
Oxygen desaturation (mild, short)	4	1.8 (0.2–3.5)	1.6 (0.4–3.4)	9.2 (2.9–18.1)	3.7 (1.1–8.2)	1.9 (1.6–2.5)	1.5 (0.7–3.0)	49.8 (30.6–69.0)	13.8 (7.0–22.4)	0.6 (0.2–1.1)
Hypertension	5	0.0 (0.0–0.2)	0.0 (0.0–0.1)	0.0 (0.0–0.1)	0.0 (0.0–0.0)	5.4 (4.3–8.2)	5.5 (0.0–15.5)	6.6 (1.1–20.4)	0.0 (0.0–0.0)	0.0 (0.0–0.0)
Apnea (not prolonged)	6	0.9 (0.4–1.7)	4.1 (0.7–18.2)	6.2 (3.7–10.5)	2.5 (0.4–9.6)	2.1 (1.7–2.9)	3.1 (1.7–5.5)	50.7 (27.9–68.6)	28.2 (16.5–45.1)	1.1 (0.0–4.7)
Oxygen desaturation (mild, long)	7	0.8 (0.3–3.3)	3.1 (1.7–7.0)	7.9 (5.2–21.4)	3.1 (1.2–8.6)	3.2 (2.5–3.9)	1.5 (0.4–6.3)	51.1 (36.5–66.3)	18.0 (6.9–30.6)	1.9 (0.4–6.9)
AW obstruction	8	0.0 (0.0–0.7)	2.1 (0.5–5.7)	3.0 (0.5–10.6)	1.4 (0.0–2.8)	2.5 (1.7–3.8)	0.3 (0.0–1.6)	38.6 (8.2–58.6)	4.9 (1.1–16.7)	1.5 (0.5–3.1)
Failed sedation	9	5.7 (0.3–19.3)	3.1 (0.7–10.7)	0.5 (0.0–1.7)	0.0 (0.0–0.7)	5.0 (4.0–6.4)	0.3 (0.0–1.0)	27.7 (5.4–57.2)	0.6 (0.0–2.0)	1.2 (0.0–2.7)
Apnea (long)	10	3.6 (1.3–9.6)	11.7 (6.8–19.3)	15.0 (7.8–30.0)	8.9 (5.1–13.1)	3.9 (3.2–4.4)	11.1 (5.7–20.8)	47.9 (27.8–64.2)	37.7 (21.5–53.6)	3.5 (1.5–9.3)
Allergy	11	29.0 (4.3–73.0)	0.0 (0.0–4.5)	0.2 (0.0–0.7)	0.5 (0.0–2.0)	7.1 (4.6–9.3)	10.2 (3.3–25.4)	20.9 (8.4–50.0)	0.0 (0.0–3.5)	0.0 (0.0–1.9)
Oxygen desaturation (severe)	12	2.2 (0.9–7.0)	7.9 (3.0–21.6)	16.0 (8.2–25.0)	13.4 (7.3–21.6)	4.8 (3.7–6.8)	6.7 (1.5–11.4)	80.8 (64.1–92.4)	26.7 (14.6–40.7)	14.3 (3.0–27.2)
Cardiovascular collapse	13	50.7 (28.1–73.1)	0.6 (0.0–1.3)	4.7 (1.7–9.1)	2.4 (0.0–18.0)	13.6 (8.2–20.9)	1.8 (0.0–22.8)	52.5 (28.6–84.7)	2.3 (0.9–4.5)	33.9 (17.5–47.9)
Cardiac arrest	14	55.0 (35.4–80.5)	6.3 (2.1–18.4)	6.8 (2.6–30.1)	23.5 (6.1–41.1)	18.2 (12.1–24.7)	23.3 (8.9–40.8)	61.2 (32.7–86.5)	8.2 (0.0–22.7)	46.6 (33.3–67.6)
Seizure	15	21.7 (5.4–59.4)	0.0 (0.0–0.9)	0.8 (0.0–2.2)	0.0 (0.0–12.0)	10.0 (5.6–17.4)	3.3 (0.0–9.5)	47.2 (16.8–92.8)	0.0 (0.0–1.0)	3.3 (0.0–14.0)

Notes: Median global weighted mean treatment response per AE (%) and mean time to resolve (min). Values are derived from 10,000 bootstrap resampling replicates of reported survey data, followed by IQRs in parentheses. Ranks range from most frequently (as found to be reported in this study) observed AEs (1) to least frequently observed AEs (15).

Abbreviations: AE, adverse event; AW, airway; IQRs, interquartile ranges; IV, intravenous; min, minutes.

Table 4 Costs of AEs

AE	Rank	France (EUR)	Germany (EUR)	Italy (EUR)	UK (GBP)	US (USD)	Worlda (USD)
Hypotension	1	23 (18–28)	6 (4–8)	9 (6–13)	14 (10–18)	210 (154–269)	43 (27–68)
Bradycardia	2	11 (7–15)	5 (3–7)	7 (5–10)	14 (9–19)	63 (40–87)	25 (13–45)
Tachycardia	3	43 (31–54)	5 (3–6)	7 (4–11)	68 (43–86)	198 (128–285)	53 (25–101)
Oxygen desaturation (mild, short)	4	16 (11–21)	10 (7–15)	10 (7–14)	20 (11–28)	436 (319–544)	53 (27–98)
Hypertension	5	24 (15–30)	6 (5–7)	9 (5–12)	37 (26–49)	114 (70–162)	46 (24–74)
Apnea (not prolonged)	6	24 (18–32)	73 (26–113)	18 (11–24)	16 (9–24)	340 (237–434)	70 (36–128)
Oxygen desaturation (mild, long)	7	29 (20–38)	11 (5–15)	11 (7–15)	20 (12–28)	367 (281–459)	57 (31–108)
AW obstruction	8	20 (9–30)	19 (13–28)	15 (7–23)	17 (8–26)	196 (54–291)	57 (7–134)
Failed sedation	9	43 (15–56)	22 (12–31)	15 (12–18)	32 (15–49)	183 (71–310)	80 (30–142)
Apnea (long)	10	46 (34–57)	92 (67–119)	16 (9–25)	38 (23–54)	372 (263–493)	110 (59–205)
Allergy	11	8 (1–13)	12 (8–16)	16 (8–24)	63 (32–92)	479 (209–707)	48 (11–148)
Oxygen desaturation (severe)	12	55 (41–70)	66 (37–88)	35 (24–45)	39 (22–55)	501 (379–617)	130 (68–223)
Cardiovascular collapse	13	46 (31–62)	122 (83–163)	19 (7–28)	180 (131–233)	1,986 (1,456–2,513)	217 (90–447)
Cardiac arrest	14	70 (40–102)	188 (141–234)	66 (48–84)	597 (441–823)	3,597 (3,108–4,055)	575 (312–921)
Seizure	15	24 (10–39)	75 (48–109)	26 (12–41)	78 (26–122)	808 (584–1,015)	116 (29–270)

Notes: Median costs (direct costs, not fully-loaded) were calculated from average treatment patterns by country or globally (from 10,000 bootstrap replicates) multiplied by mean costs per AE. Values for AE costs are followed by IQRs in parentheses.

a For global medians (mean values for overall reported procedural sedation costs), costs were converted from each corresponding currency to USD using the average annual currency conversion rate. Ranks range from most frequently (as found to be reported in this study) observed AEs (1) to least frequently observed AEs (15).

Abbreviations: AE, adverse event; AW, airway; IQR, interquartile range.

Table 5 Global AE outcomes

AE/outcome	Rank	Procedures delayed (%)	Procedures terminated (%)	Unplanned inpatient stays (%)	Length of hospital stay (days)	Permanent neurological defect (%)	Death (%)
Hypotension	1	4.0 (1.9–7.2)	4.0 (2.3–8.5)	3.6 (1.9–7.8)	1.3 (1.1–1.7)	0.5 (0.2–0.9)	0.2 (0.1–0.4)
Bradycardia	2	2.4 (1.3–5.1)	2.8 (1.4–5.5)	2.6 (1.4–5.6)	1.2 (1.1–1.9)	0.2 (0.0–0.6)	0.1 (0.0–0.3)
Tachycardia	3	2.1 (1.1–3.5)	2.0 (1.2–2.9)	4.0 (1.1–7.5)	1.4 (1.2–1.8)	0.1 (0.0–0.2)	0.1 (0.0–0.3)
Oxygen desaturation (mild, short)	4	5.3 (2.6–8.9)	4.5 (2.2–8.3)	4.2 (1.8–8.6)	2.2 (1.7–3.3)	0.2 (0.0–0.6)	0.2 (0.0–0.4)
Hypertension	5	3.3 (1.5–5.2)	1.9 (1.0–2.8)	2.4 (1.1–3.8)	1.8 (1.4–2.0)	0.0 (0.0–0.1)	0.0 (0.0–0.1)
Apnea (not prolonged)	6	6.2 (2.6–9.9)	5.8 (2.2–12.3)	6.5 (1.6–11.4)	1.6 (1.1–2.2)	0.3 (0.1–0.7)	0.1 (0.0–0.1)
Oxygen desaturation (mild, long)	7	6.3 (3.7–9.5)	2.8 (1.1–5.6)	3.6 (2.1–5.9)	1.4 (1.1–1.8)	0.3 (0.1–0.6)	0.2 (0.0–0.3)
AW obstruction	8	5.0 (2.3–10.8)	5.0 (1.5–11.6)	5.0 (2.0–7.0)	1.9 (1.3–2.0)	0.1 (0.0–0.2)	0.0 (0.0–0.2)
Failed sedation	9	6.9 (4.3–10.0)	8.8 (4.4–14.1)	4.5 (1.2–9.9)	1.3 (1.0–1.4)	0.0 (0.0–0.0)	0.0 (0.0–0.0)
Apnea (long)	10	6.5 (3.8–12.5)	5.1 (2.2–8.3)	4.7 (2.3–14.3)	1.8 (1.4–2.0)	0.3 (0.1–0.7)	0.1 (0.0–0.2)
Allergy	11	9.7 (4.8–20.4)	15.4 (7.2–30.0)	13.8 (6.2–21.7)	2.1 (1.5–3.0)	0.2 (0.0–0.5)	0.3 (0.0–1.3)
Oxygen desaturation (severe)	12	19.1 (9.5–27.4)	15.0 (7.8–20.3)	20.3 (11.0–31.0)	2.2 (1.7–2.6)	0.8 (0.4–1.9)	0.6 (0.3–0.9)
Cardiovascular collapse	13	49.1 (31.7–68.0)	54.1 (35.9–76.5)	56.2 (43.4–79.6)	3.8 (3.0–4.6)	3.0 (2.2–4.0)	2.4 (1.5–3.6)
Cardiac arrest	14	85.5 (50.8–92.4)	94.0 (85.1–97.7)	98.3 (95.5–99.9)	7.6 (5.8–9.0)	24.8 (11.4–39.4)	14.0 (8.1–25.5)
Seizure	15	47.6 (25.6–75.6)	71.2 (40.9–96.4)	69.3 (44.7–84.1)	2.4 (2.0–2.9)	1.8 (0.0–8.0)	0.2 (0.0–1.1)

Notes: Median global weighted mean outcomes per AE as percentages or length of unplanned hospital stays in days. Values are derived from 10,000 bootstrap resampling replicates of reported survey data. Ranks range from most frequently (as found to be reported in this study) observed AEs (1) to least frequently observed AEs (15). Values in the parentheses are the interquartile range (IQR).

Abbreviations: AE, adverse event; AW, airway.