Comparison of Propofol-nalbuphine and Propofol-fentanyl Sedation for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography

A Double-blind, Randomized Controlled Trial

Peiqi Wang; Yan Chen; Ying Guo; Jiangbei Cao; Hong Wang; Weidong Mi; Longhe Xu

BMC Anesthesiol. 2022;22(47)

Abstract and Introduction

Abstract

Background: Endoscopic retrograde cholangiopancreatography (ERCP) has been increasingly used to treat patients with biliary/pancreatic duct obstruction or stricture outside the operating room. Effective and safe sedation techniques are needed because of painful stimuli and the long duration of the ERCP procedure. Nalbuphine has been shown to cause less respiratory depression during sedation than similar cases without nalbuphine. This study compared the effects of propofol-nalbuphine (PN) and propofol-fentanyl (PF) sedation in patients undergoing ERCP.

Methods: Four hundred patients scheduled for ERCP procedures were divided into two groups: the PF group (receiving PF sedation,n = 199) and the PN group (receiving PN sedation,n = 201). Vital signs, adverse events during surgery, patient movement scores, pain scores, and adverse events one day post-ERCP were recorded.

Results: Stable haemodynamics were observed in both groups. Compared to the PF group, the PN group showed significantly decreased respiratory depression (P < 0.0001) and surgical interruptions (P = 0.048). Nalbuphine decreased patient movement by reducing pain from ERCP.

Conclusion: Nalbuphine, instead of fentanyl, precipitated less respiratory depression while permitting adequate/equivalent sedation for ERCP and therefore provides more efficient and safer sedation.

Trial Registration: ChiCTR, ChiCTR1800016018, Registered 7 May 2018, http://www.chictr.org.cn/showproj.aspx?proj=27085

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Abstract and Introduction
Background
Methods
Results
Discussion
Conclusions
References

Table 1. Patient characteristics and procedure details
	GroupPF(n = 199)	GroupPN(n = 201)
Age(yr)	58.09 ± 13.51	57.91 ± 13.42
Age range(yr)	21–79	24–79
Age grouping(n, 18–64/65–79 yr)	132/67	133/68
Gender(male/female)	132/67	124/77
BMI(kgm⁻²)	22.68 ± 3.63	22.86 ± 3.15
Mallampati Class(n, I/II/III)	14/183/2	13/185/3
ASA grading(n, I/II/III)	22/131/46	19/132/50
Duration of anaesthesia(min)	44.91 ± 28.77	43.73 ± 24.76
Duration of operation(min)	37.43 ± 27.96	36.62 ± 24.15
ERCP indication(n,%)
Choledocholithiasis	105(52.76%)	93(46.28%)
Gall bladder carcinoma	16(8.04%)	15(7.47%)
Biliary strictures	16(8.04%)	22(10.95%)
Pancreatic pathology	24(12.06%)	33(16.39%)
Pancreatic carcinoma	20(10.05%)	23(11.44%)
Others	18(9.05%)	15(7.47%)

Table 2. Adverse events and interruptions during the procedure
	GroupPF(N = 199)	GroupPN(N = 201)	p value	95% CI	Odds ratio
Respiratory depression(n)%^a	24 (12.06%)	12 (5.97%)	< 0.0001	1.04–3.93	2.16
subclinical respiratory^a depression(n)%^a	10 (5.03%)	6 (2.99%)	0.14	0.86–1.88	1.72
hypoxia(n)%^a	14 (7.04%)	6 (2.99%)	0.03	1.06–1.95	2.46
minor risk hypoxia(n)%^a	9(4.52%)	5(2.49%)	0.13	0.87–1.96	1.86
severe risk hypoxia(n)%^a	5(2.51%)	1(0.50%)	0.048	1.17–2.45	1.69
18–65y Age-related Respiratory depression(n)%^a	15(11.36%)	7(5.26%)	< 0.0001	1.04–1.94	2.31
66–80y Age-related Respiratory depression(n)%^a	9(13.43%)	5(7.35%)	< 0.0001	0.87–2.07	1.96
Correction of hypoxia(n)%^a	24 (12.06%)	12 (5.97%)	< 0.0001	1.04–3.93	2.16
Method I(n)%^a	12 (6.03%)	8 (3.98%)	0.24	0.84–1.77	1.55
Methods I + II(n)%^a	4 (2.01%)	1 (0.50%)	0.09	1.03–2.54	1.62
Methods I + II + III(n)%^a	6 (3.02%)	3 (1.49%)	0.15	0.84–2.17	2.05
Methods I + II + III + IV(n)%^a	2 (1.01%)	0 (0.00%)	0.07	1.83–2.23	2.02
Surgical interruptions(n)%^a	45 (22.61%)	30 (14.93%)	0.02	1.02–1.57	1.27
The score for patient movement(points)^b	9.61 ± 1.01	9.59 ± 1.07	0.37	-0.23–0.25	–––

Values are presented as the frequency (%), Chi-squared test^a. Values are presented as the mean ± SD, one-sample t test^b. Methods: (I) opening the airway with the jaw-thrust manoeuvre; (II) placing the nasopharyngeal airway; (III) turningthe patients over to the supine position; and (IV) tracheal intubation for mechanical ventilation

Table 3. Total dose of drugs given during ERCP
Total dose of drugs	GroupPF(n = 199)	GroupPN(n = 201)
Midazolam(mg)^b	1.09 ± 0.26	1.09 ± 0.25
Propofol(mg)^b	229.4 ± 139.0	234.6 ± 118.2
Study drug(ml)^b	2.21 ± 0.62	2.14 ± 0.53
Intravenous ephedrine(n,%)^a	7 (3.52%)	7 (3.48%)
Atropine(n,%) ^a	15 (7.54%)	20 (9.95%)

Values are presented as the frequency (%), Chi-squared test^a. Values are presented as the mean ± SD, one-sample t test^b. Study drug: fentanyl (50 μg/ml) or nalbuphine (5 mg/ml)

Table 4. Satisfaction score and hospitalization days
	GroupPF(n = 199)	GroupPN(n = 201)
Endoscopist score(n, I/II/III)^a	188/8/3	189/11/1
Anaesthesiologistscore(n, I/II/III)^a	178/19/2	185/15/1
PSSI score(points)^b	21.10 ± 3.82	21.01 ± 4.08
Hospitalization days(d)^b	7.93 ± 9.80	7.42 ± 7.02

Values are presented as the frequency (%), Chi-squared test^a. Values are presented as the mean ± SD, One-sample t test^b. Score:(I)satisfactory;(II)indeterminate;(III)not satisfactory. PSSI: patient sedation satisfactionassessment tool. Hospitalization days: time for discharge after surgery

Table 5. Adverse eventsone day after ERCP
	GroupPF(N = 199)	GroupPN(N = 201)	P value	95% CI	Odds ratio
Total adverse events(n)%^a	49(23.62%)	52(25.88%)	0.38	0.77–1.22	0.94
Nausea(n)%^a	20 (10.05%)	18 (8.96%)	0.35	0.78–1.47	1.14
Vomiting(n)%^a	11 (5.53%)	11 (5.47%)	0.49	0.65–1.55	1.01
Pruritus(n)%	0	0	NS
Aspiration pneumonia(n)%	0	0	NS
Cough(n)%	0	0	NS
Polypnea and dyspnoea(n)%^a	1 (0.50%)	1 (0.50%)	0.50	0.25–4.03	1.01
Abdominal pain(n)%^a	15 (7.54%)	16 (7.96%)	0.44	0.67–1.42	0.94
VAS score(points)^b	0.16 ± 0.75	0.13 ± 0.62	0.11	-0.03–0.15	––-
Fever(n)%^a	2 (1.01%)	6 (2.99%)	0.08	0.15–1.66	0.33
Medical treatment for adverse events(n)%^a	17 (8.54%)	18 (8.96%)	0.44	0.8–1.39	0.95

Values are presented as the frequency (%), Chi-squared test^a. Values are presented as the mean ± SD. One-sample t test ^b. VAS score visual analogue score, NA not available