Efficacy and Safety Profile of Remimazolam-alfentanil Combination for ERCP Sedation
NCT ID: NCT04658173
Last Updated: 2021-12-20
Study Results
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Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2020-12-22
2023-10-01
Brief Summary
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Detailed Description
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1. Title:A randomized, controlled trial to compare the efficacy and safety profile of a remimazolam-alfentanil combination with a propofol-alfentanil combination for ERCP.
2. Research center: Single center.
3. The Design of the study: Randomized, double-blind, controlled study.
4. The population of the study: Age is between 18 and 85 years; ASA I-III levels; Patients undergone elective ERCP surgery, non-intubation patients;
5. Sample size: Based on Akhondzadeh R et al. research, propofol based sedation resulted in 43% patients present oxygen desaturation, and assuming a 15% reduction in hypoxic events in remimazolam group. From this, we have estimated that oxygen desaturation rate will be 43% in the propofol group and 28 % in the remimazolam group. We have estimated that, with a sample size of 207 patients, the study will have 80% power to detect a significant difference using the log-rank test. We have estimated that the rate of dropout or withdrawal will be approximately 20%, and thus we plan to enroll 259 patients each group
6. Interventions: Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed.
Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope,propofol 0.5mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed.
7. Outcome： Primary outcome： The occurrence of hypoxia, defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) \< 90% of any duration.
Secondary outcome： Number of events of hypoxia, defined as desaturation \< 90%. The mean number of events during the procedure will be compared between the two groups.
Lowest recorded SpO2 during the procedure. Requirement of minor airway manoeuvres: jaw lift/jaw thrust, nasopharyngeal airway insertion.
Requirement of major airway manoeuvres: bag mask ventilation, endotracheal intubation.
Total alfentanyl dose. The mean values (the doses in micrograms) during the procedure will be compared between the two groups.
Requirement of antispasmodic agent. Proportion of patients requiring this medication will be compared between the two groups.
Endoscope re-insertion rate. Rescued sedation: drugs dose. Total duration of procedure. Duration under sedation/anaesthesia. Successful completion of the procedure: Yes/No. Proportion of patients fulfilling this criterion will be compared between the two groups.
Sensation of abdominal bloating: Y/N. Proportion of patients experiencing this adverse event will be compared between the two groups.
Patients' satisfaction score on leaving recovery: 5 points numerical rating scale: Very satisfied (5), somewhat satisfied (4), neither satisfied nor dissatisfied (3), somewhat dissatisfied (2), very dissatisfied (1). Proportion of patients at a particular threshold will be compared between the two groups.
The endoscopist assessed the ease of performing at the end of the procedure as I-satisfactory, II-difficult or III-impossible.
QOR-15. Recovery time :The time to recovery based on Modified Aldrete score was noted every 5 minutes, starting from the time of endoscope removal . A score of 9 was considered as recovery and the patient was discharged to the ward.The estimated duration of the study:2-3 years.
If the procure is expected more than 1 hour, the arterial blood gas (ABG) will be detected before and after the ERCP, and the serum Aβ1-40 will be also determined by the commercial kits.
8. Adverse events:
Incidence of hypertention, hypotension，tachycardia , bradycardia，nausea，vomiting, POD, Sensation of abdominal bloating, The dosage of urapidil, ephedrine, atropine and esmolol during the observation period
9. Safety consideration: ECG, HR, MAP, respiratory rate was monitored.
10. Statistical analysis Mean and standard deviation values will be estimated for continuous outcomes while frequency and percentage will be computed for binary outcomes. 95% confidence intervals around the point estimate will be calculated where appropriate for the primary and secondary outcomes. Descriptive statistics will be used to present the results. P \< 0.05 will be considered significant. Analyses will be intention-to-treat from randomisation. All randomised cases will be included in the analyses, regardless of missing data. As the data capture is only limited to a few hours after the intervention and the investigators are directly involved in the conduct of the study, we anticipate very few missing data. A subgroup analyses will be attempted (if feasible)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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remimazolam-alfentanil combination
Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
remimazolam-alfentanil combination
Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
propofol-alfentanil combination
Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1.5 to 2mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
propofol-alfentanil combination
Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs，and alfentanil 5ug/kg when additional analgesia is needed
Interventions
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remimazolam-alfentanil combination
Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
propofol-alfentanil combination
Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs，and alfentanil 5ug/kg when additional analgesia is needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I-III levels;
* Patients undergone elective ERCP surgery, non-intubation patients;
Exclusion Criteria
* BMI\<18 or BMI\>30;
* Abnormal renal function ;
* Previous abnormal surgical anesthesia recovery history;
* Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
* Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
* Expected difficult intubation ;
* Opioids allergy history;
* Take monoamine oxidase inhibitor or antidepressant within 15 days;
* Pregnant or parturient women;
* Involved in other drug trials within three months;
* Patients who can not communicate well with the researcher
18 Years
85 Years
ALL
No
Sponsors
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Tianjin Nankai Hospital
OTHER
Responsible Party
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Jianbo Yu
Director
Principal Investigators
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Jianbo Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Nankai Hospital
Locations
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Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, China
Tianjin NanKai hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jianbo Yu, MD
Role: primary
Role: backup
Jianbo Yu, MD,PhD
Role: primary
References
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Akhondzadeh R, Ghomeishi A, Nesioonpour S, Nourizade S. A comparison between the effects of propofol-fentanyl with propofol-ketamine for sedation in patients undergoing endoscopic retrograde cholangiopancreatography outside the operating room. Biomed J. 2016 Apr;39(2):145-9. doi: 10.1016/j.bj.2015.11.002. Epub 2016 Jun 21.
Mazanikov M, Udd M, Kylanpaa L, Mustonen H, Lindstrom O, Farkkila M, Halttunen J, Poyhia R. A randomized comparison of target-controlled propofol infusion and patient-controlled sedation during ERCP. Endoscopy. 2013 Nov;45(11):915-9. doi: 10.1055/s-0033-1344712. Epub 2013 Oct 8.
Eberl S, Koers L, van Hooft J, de Jong E, Hermanides J, Hollmann MW, Preckel B. The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial. Eur J Anaesthesiol. 2020 May;37(5):394-401. doi: 10.1097/EJA.0000000000001134.
Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.
Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.
Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.
Goyal R, Hasnain S, Mittal S, Shreevastava S. A randomized, controlled trial to compare the efficacy and safety profile of a dexmedetomidine-ketamine combination with a propofol-fentanyl combination for ERCP. Gastrointest Endosc. 2016 May;83(5):928-33. doi: 10.1016/j.gie.2015.08.077. Epub 2015 Sep 11.
Thiruvenkatarajan V, Dharmalingam A, Arenas G, Wahba M, Steiner R, Kadam VR, Tran A, Currie J, Van Wijk R, Quail A, Ludbrook G. High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial. Trials. 2020 May 29;21(1):444. doi: 10.1186/s13063-020-04378-z.
Eberl S, Koers L, van Hooft JE, de Jong E, Schneider T, Hollmann MW, Preckel B. Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial. Trials. 2017 Oct 11;18(1):472. doi: 10.1186/s13063-017-2197-8.
Other Identifiers
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NKYY_YXKT_IRB_2020_063_01
Identifier Type: -
Identifier Source: org_study_id