Efficacy and Safety Profile of Remimazolam-alfentanil Combination for ERCP Sedation

NCT04658173 | Unknown

• 1 other identifier: NKYY_YXKT_IRB_2020_063_01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

Moderate to deep levels of sedation and analgesia are required for ERCP. Propofol-based sedation is simple, easy to use, and effective, but is not without cardiovascular and respiratory adverse effects. The combination of remimazolam and alfentanil has shown promising results for sedation in other similar scenarios. The aim of this study was to compare the efficacy and safety of a standard propofol-alfentanil regimen with a remimazolam-alfentanil combination.

Conditions

Anesthesia

Keywords

ERCP; Propofol; Remimazolam; Alfentanil

Outcome Measures

Primary Outcomes (1)

• The number of hypoxia

  defined by any event of SpO2 (oxygen saturation measured by pulse oximetry) \< 90% of any duration.

  1 day

Secondary Outcomes (16)

• Number of events of hypoxia, defined as desaturation < 90%.

  1 day

• Lowest recorded SpO2 during the procedure

  1 day

• the number of requirement for minor airway manoeuvres

  1 day

• the number of requirement for major airway manoeuvres

  1 day

• Total alfentanyl dose

  1 day

Study Arms (2)

remimazolam-alfentanil combination

EXPERIMENTAL

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

Drug: remimazolam-alfentanil combination

propofol-alfentanil combination

ACTIVE COMPARATOR

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

Drug: propofol-alfentanil combination

Interventions

remimazolam-alfentanil combination DRUG

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

Also known as: RA Combination

remimazolam-alfentanil combination

propofol-alfentanil combination DRUG

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

Also known as: PA combination

propofol-alfentanil combination

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is between 18 and 85 years
• ASA I-III levels;
• Patients undergone elective ERCP surgery, non-intubation patients;

You may not qualify if:

• Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
• 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

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (2)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300100, China

RECRUITING

Tianjin NanKai hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 27372170 RESULT

• 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.

  PMID: 24104763 RESULT

• 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.

  PMID: 31860599 RESULT

• 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.

  PMID: 29723512 RESULT

• 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.

  PMID: 30292760 RESULT

• 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.

  PMID: 22190555 RESULT

• 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.

  PMID: 26364968 RESULT

• 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.

  PMID: 32471494 RESULT

• 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.

  PMID: 29020995 RESULT

MeSH Terms

Interventions

clindamycin, tretinoin drug combination

Study Officials

• Jianbo Yu, MD

  Tianjin Nankai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianbo Yu, MD

CONTACT

86-22-27435873; yujianbo11@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: December 22, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)