Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial

Abstract

Introduction: Patients undergoing heart valve surgery are predominantly transferred postoperatively to the intensive care unit (ICU) under continuous sedation. Volatile anaesthetics are an increasingly used treatment alternative to intravenous substances in the ICU. As subject to inhalational uptake and elimination, the resulting pharmacological benefits have been repeatedly demonstrated. Therefore, volatile anaesthetics appear suitable to meet the growing demands of fast-track cardiac surgery. However, their use requires special preparation at the bedside and trained medical and nursing staff, which might limit the pharmacological benefits. The aim of our work is to assess whether the temporal advantages of recovery under volatile sedation outweigh the higher effort of special preparation.

Methods and analysis: The study is designed to evaluate the differences between intravenous sedatives (n=48) and volatile sedatives (n=48) in continued intensive care sedation. This study will be conducted as a prospective, randomised, controlled, single-blinded, monocentre trial at a German university hospital in consenting adult patients undergoing heart valve surgery at a university hospital. This observational study will examine the necessary preparation time, staff consultation and overall feasibility of the chosen sedation method. For this purpose, the continuation of sedation in the ICU with volatile sedatives is considered as one study arm and with intravenous sedatives as the comparison group. Due to rapid elimination and quick awakening after the termination of sedation, closer consultation between the attending physician and the ICU nursing staff is required, in addition to a prolonged setup time. Study analysis will include the required setup time, time from admission to extubation as primary outcome and neurocognitive assessability. In addition, possible operation-specific (blood loss, complications), treatment parameters (catecholamine dosages, lung function) and laboratory results (acute kidney injury, acid base balance (lactataemia), liver failure) as influencing factors will be collected. The study-relevant data will be extracted from the continuous digital records of the patient data management system after the patient has been discharged from the ICU. For statistical evaluation, 95% CIs will be calculated for the median time to extubation and neurocognitive assessability, and the association will be assessed with a Cox regression model. In addition, secondary binary outcome measures will be evaluated using Fisher's exact tests. Further descriptive and exploratory statistical analyses are also planned.

Ethics and dissemination: The study was approved by the Institutional Ethics Board of the University of Frankfurt, Germany (#20-1050). Informed consent of all individual patients will be obtained before randomisation. Results will be disseminated via publication in peer-reviewed journals.

Trial registration number: Clinical trials registration (NCT04958668) was completed on 1 July 2021.

Keywords: adult intensive & critical care; cardiac surgery; health economics; thoracic surgery; valvular heart disease.

Conflict of interest statement

Competing interests: ANF received speaker fees from P.J. Dahlhausen & Co. GmbH, Colone, Germany and received the Sedana Medical Research Grant 2020. The author confirms that the disclosed conflicts of interest of ANF does not alter the adherence to BMJ Open policies on sharing data and materials. EHA received a research grant of the German Research Foundation (AD 592/1-1). The author confirms that the disclosed conflicts of interest of EHA does not alter the adherence to BMJ Open policies on sharing data and materials. KZ has received honoraria for participation in advisory board meetings for Haemonetics and Vifor and received speaker fees from CSL Behring and GE Healthcare. He is the Principal Investigator of the EU-Horizon 2020 project ENVISION (Intelligent plug-and-play digital tool for real-time surveillance of COVID-19 patients and smart decision-making in Intensive Care Units). The author confirms that the disclosed conflicts of interest of KZ does not alter the adherence to BMJ Open policies on sharing data and materials. FJR received speaker fees from Helios Germany, university hospital Würzburg and Keller Medical GmbH. FJR received financial support by HemoSonics LLC, pharma-consult Petersohn and Boehringer Ingelheim. The author confirms that the disclosed conflicts of interest of FJR does not alter the adherence to BMJ Open policies on sharing data and materials.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Flow chart of the study design for the evaluation of volatile sedation in postoperative intensive care in patients recovering from heart valve surgery. ICU, intensive care unit.