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)

Conclusions

In conclusion, we demonstrated that sedation with propofol-nalbuphine had advantages over propofol-fentanyl for the ERCP procedure because the former produced less respiratory depression and surgical interruption. Furthermore, nalbuphine can produce adequate analgesia and help to maintain stable haemodynamics in patients undergoing ERCP. Therefore, acombination of propofol and nalbuphineis more efficient and safer for patients during procedural sedation in ERCP.

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Abbreviations
ERCP: Endoscopic retrograde cholangiopancreatography; PN: Propofolnalbuphine; PF: Propofol-fentanyl; MRCP: Magnetic resonance cholangiopancreatography; EUS: Endoscopic ultrasound; PLA: Chinese People's Liberation Army; BMI: Body mass index; ASA: American Society of Anesthesiologists; BIS: Bispectral index; HR: Heart rate; NBP: Noninvasive mean blood pressure; RR: Respiratory rate; SpO2: Oxygen saturation; PSSI: Patient sedation satisfaction assessment tool; VAS: Visual analogue score.

Acknowledgements
An independent data analysis was commissioned by the Medical Management Institute for Public Health (PLA General Hospital, China) who formatted the data for analysis and undertook a preliminary interrogation of the data. Data collection would not have beenpossible without the assistance of Weili Zhang and Yan Wang. The authors acknowledge the contribution of colleagues.

Funding
Not funded

Availability of data and materials
All data generated or analysed during this study are included in this published article.

Declarations
Ethics approval and consent to participate
This study was approved by the ethics committee of Chinese PLA General Hospital (S2017-075–02) and was registered in the Chinese Clinical Trial Registry (ChiCTR1800016018). All patients provided written informed consent to participate, and this study was completed in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Consent for publication
Not applicable

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