Skip to main content
SpringerLink
Log in

Controlled sedation with midazolam and analgesia with nalbuphine to alleviate pain in patients undergoing subcutaneous implantable cardioverter defibrillator implantation

  • Published:
Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Purpose

Subcutaneous implantable cardioverter defibrillator (S-ICD) is an alternative to transvenous ICD to prevent sudden cardiac death. Subcutaneous ICD implantation frequently requires general anesthesia because of procedure nociceptive steps during creation of a large device pocket and lead tunneling. This study aims to determine if a strategy of operator-guided controlled sedation with midazolam and analgesia with nalbuphine is effective in alleviating pain during S-ICD implantation.

Methods

This prospective study included consecutive patients undergoing S-ICD implantation under controlled sedation with midazolam and combined analgesia with nalbuphine. The Critical-Care Pain Observation Tool (CPOT), a behavioral pain scale, was used for pain assessment during S-ICD placement and the Numeric Rate Scale (NRS) was used for evaluation of pain recollection after patient recovery. CPOT score of 3 or above and NRS score of 4 or above are considered to be associated with significant pain.

Results

Sixteen patients were included in this study: Ten men (62.5%) and six women with a mean age of 54 ± 11 years. Indication for S-ICD implantation was primary prevention in 11 patients (68.8%). Mean dose of administrated midazolam and nalbuphine was 0.11 ± 0.03 and 0.27 ± 0.05 mg/kg, respectively. Mean CPOT during the whole procedure was 1.4 ± 1.6. No patient presented procedural pain recollection as all 16 patients had NRS score less than 4. No serious adverse event related to sedation occurred during S-ICD implantation.

Conclusions

This study suggests that operator-guided controlled sedation with midazolam and analgesia with nalbuphine is effective to alleviate procedural pain in patients undergoing S-ICD implantation and may constitute an alternative to general anesthesia.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Abbreviations

S-ICD:

Subcutaneous implantable cardiovertor defibrillator

T-ICD:

Transvenous implantable cardiovertor defibrillator

CS:

Controlled sedation

CPOT:

Critical-Care Pain Observation Tool

NRS:

Numerical Rating Scale

References

  1. Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363:36–44.

    Article  CAS  PubMed  Google Scholar 

  2. Lambiase PD, Barr C, Theuns DA, et al. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014;35:1657–65.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am CollCardiol. 2012;60:1933–9.

    Article  Google Scholar 

  4. Burke MC, Gold MR, Knight BP, et al. Safety and efficacy of the totally subcutaneous implantable defibrillator: 2-year results from a pooled analysis of the IDE Study and EFFORTLESS Registry. J Am CollCardiol. 2015;65:1605–15.

    Article  Google Scholar 

  5. Cappato R, Smith WM, Hood MA, Crozier IG, Jordaens L, Spitzer SG, et al. Subcutaneous chronic implantable defibrillation systems in humans. J Interv Card Electrophysiol. 2012;34:325–32.

    Article  PubMed  Google Scholar 

  6. Priori SG, Blomström-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the task force for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death of the European Society of Cardiology (ESC). Europace. 2015;17:1601–87.

    PubMed  Google Scholar 

  7. Bongiorni MG, Proclemer A, Dobreanu D, Marinskis G, Pison L, Blomstrom-Lundqvist C, et al., Scientific Initiative Committee, European Heart Rhythm Association. Preferred tools and techniques for implantation of cardiac electronic devices in Europe: results of the European Heart Rhythm Association survey. Europace. 2013;15:1664–8.

  8. Essandoh MK, Portillo JG, Weiss R, et al. Anesthesia care for subcutaneous implantable cardioverter/defibrillator placement: a single-center experience. J Clin Anesth. 2016;31:53–9.

    Article  PubMed  Google Scholar 

  9. Knops RE, Olde Nordkamp LR, de Groot JR, Wilde AA. Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2013;10:1240–3.

    Article  PubMed  Google Scholar 

  10. Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974;2:656–9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Gélinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006;15:420–7.

    PubMed  Google Scholar 

  12. Breivik H, Borchgrevink PC, Allen SM, et al. Br J Anaesth. 2008;101:17–24.

    Article  CAS  PubMed  Google Scholar 

  13. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. American College of Critical Care Medicine. Crit Care Med. 2013;41:263–306.

    Article  PubMed  Google Scholar 

  14. Chanques G, Viel E, Constantin JM, et al. The measurement of pain in intensive care unit: comparison of 5 self-report intensity scales. Pain. 2010;151:711–21.

    Article  PubMed  Google Scholar 

  15. Gélinas C, Harel F, Fillion L, Puntillo KA, Johnston CC. Sensitivity and specificity of the critical-care pain observation tool for the detection of pain in intubated adults after cardiac surgery. J Pain Symptom Manag. 2009;37:58–67.

    Article  Google Scholar 

  16. Marquié C, Duchemin A, Klug D, et al. Can we implant cardioverter defibrillator under minimal sedation? Europace. 2007;9:545–50.

    Article  PubMed  Google Scholar 

  17. Wasserlauf J, Knight BP, Li Z, et al. Moderate sedation reduces lab time compared to general anesthesia during cryoballoon ablation for AF without compromising safety or long-term efficacy. Pacing Clin Electrophysiol. 2016;39:1359–65.

    Article  PubMed  Google Scholar 

  18. Guerra F, Pavoni I, Romandini A, et al. Feasibility of a cardiologist-only approach to sedation for electrical cardioversion of atrial fibrillation: a randomized, open-blinded, prospective study. Int J Cardiol. 2014;176:930–5.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Assistance Publique-Hôpitaux de Marseille (APHM), Department of Cardiology, Nord Hospital, Aix-Marseille University, Chemin des Bourrely, 13915, Marseille Cedex 20, France

    Michaël Peyrol, Jérémie Barraud, Jennifer Cautela, Marc Laine, Laurent Bonello, Franck Thuny & Franck Paganelli

  2. Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France

    Michaël Peyrol, Jennifer Cautela, Marc Laine, Laurent Bonello & Franck Thuny

  3. Assistance Publique-Hôpitaux de Marseille (APHM), Department of Cardiology, Timone Hospital, Aix-Marseille University, Marseille, France

    Baptiste Maille, Frédéric Franceschi & Linda Koutbi

  4. Aix-Marseille University, Marseille, France

    Samuel Levy

Authors
  1. Michaël Peyrol
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jérémie Barraud
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jennifer Cautela
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Baptiste Maille
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Marc Laine
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Laurent Bonello
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Franck Thuny
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Franck Paganelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Frédéric Franceschi
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Linda Koutbi
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Samuel Levy
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Michaël Peyrol.

Ethics declarations

Conflict of interest

Dr. Michael Peyrol received Honoraria from Boston Scientific for speaking at symposia (<5000 USD).

Funding

None.

Ethical approval

This study complies with the Declaration of Helsinki. The research protocol was approved by the Research Ethical Committee of Aix-Marseille University.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Peyrol, M., Barraud, J., Cautela, J. et al. Controlled sedation with midazolam and analgesia with nalbuphine to alleviate pain in patients undergoing subcutaneous implantable cardioverter defibrillator implantation. J Interv Card Electrophysiol 49, 191–196 (2017). https://doi.org/10.1007/s10840-017-0255-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10840-017-0255-5

Keywords

Search

Navigation