Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595277
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Neuromuscular Blocking Agents in Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Clinical Practices for the Management of Neuromuscular Blocking Agents in Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Background
Neuromuscular blocking agents NMBA are commonly used in cardiac surgery anesthesia to facilitate airway management and ventilation and ensure optimal operative conditions To improve post-operative results and reduce the length of stay in the intensive care unit the concept of Fast track anesthesia is coming into force which includes all techniques that offer extubation within 1-6 hours post-operatively Fast-track cardiac surgery is only feasible when short-acting NMBA are used and neuromuscular transmission has returned to normal by the end of the operation or just before extubation a few hours after surgery This requires quantitative monitoring of muscle strength the only way to eliminate residual paralysis defined by a TOF ratio 09 The American Society of Anesthesiologists ASA and the European Society of Anesthesiology and Intensive Care EASIC recommend quantitative measurement of neuromuscular block until extubationThis is the only way to avoid the complications of residual paralysis essentially postoperative pulmonary complications The POPULAR study clearly highlighted the shortcomings of current NMBA management out of a total population of 17150 patients only 165 were extubated with a TOF ratio greater than 090 Cardiac surgery patients are brought to the ICU still sedated intubated and ventilated Neuromuscular blocking agents are usually discontinued at the end of surgery As awakening and extubation take place later in the ICU clinicians often consider that the action of neuromuscular blocking agents is over but without making a quantitative measurement as recommended by the guidelines
2 Objectives of the clinical research project
21 Primary objective The primary objective of this single-center prospective observational study is to systematically monitor the degree of postoperative curarization up to the time of extubation and to assess the degree of adherence of intensive care teams to extubation recommendations based on quantitative measurements of the degree of neuromuscular junction block
22 Secondary objectives Quantify NMBA doses used duration of action duration of recovery
3 Methodology of the clinical research project
In this study we will systematically check the degree of curarization of cardiac surgery patients up to the time of extubation Prior to surgery all patients will have an explanation of the protocol and will give written informed consent for the use of their data Patient management is at the discretion of the anaesthetist in charge and will not be altered in any way by the protocol All drugs used will be standard of care At the end of the procedure one of the investigators will stay with the patient in intensive care and measure the degree of neuromuscular blockade with a curameter used as standard in clinical routine at Erasme Hospital TOFScan IdMed Marseille France All measurements will be made in accordance with Good clinical research practice GCRP in pharmacodynamic studies of neuromuscular blocking agents III This measurement will be carried out continuously until the patient is extubated or 100 neuromuscular transmission has been recovered ICU staff in charge of the patient will be blinded to the measurements done by the investigators Intensive care physicians manage the patient according to the ICU standard of care If the patient represents a residual curarization at the time of extubation the investigators will inform the ICU staff in order to avoid endangering the patient
No intervention will be made with regard to the anesthesia and post-operative monitoring protocol all medications and interventions will be considered standard of care and will be left to the discretion of the anesthesiologist and ICU team in charge
4 Design of the clinical research project
This is a prospective observational study
5 Participants
All patients undergoing cardiac surgery at Hôpital Érasme between October 1 2024 and May 31 2025
Neuromuscular blocking agents NMBA are commonly used in cardiac surgery anesthesia to facilitate airway management and ventilation and ensure optimal operative conditions To improve post-operative results and reduce the length of stay in the intensive care unit the concept of Fast track anesthesia is coming into force which includes all techniques that offer extubation within 1-6 hours post-operatively Fast-track cardiac surgery is only feasible when short-acting NMBA are used and neuromuscular transmission has returned to normal by the end of the operation or just before extubation a few hours after surgery This requires quantitative monitoring of muscle strength the only way to eliminate residual paralysis defined by a TOF ratio 09 The American Society of Anesthesiologists ASA and the European Society of Anesthesiology and Intensive Care EASIC recommend quantitative measurement of neuromuscular block until extubationThis is the only way to avoid the complications of residual paralysis essentially postoperative pulmonary complications The POPULAR study clearly highlighted the shortcomings of current NMBA management out of a total population of 17150 patients only 165 were extubated with a TOF ratio greater than 090 Cardiac surgery patients are brought to the ICU still sedated intubated and ventilated Neuromuscular blocking agents are usually discontinued at the end of surgery As awakening and extubation take place later in the ICU clinicians often consider that the action of neuromuscular blocking agents is over but without making a quantitative measurement as recommended by the guidelines
2 Objectives of the clinical research project
21 Primary objective The primary objective of this single-center prospective observational study is to systematically monitor the degree of postoperative curarization up to the time of extubation and to assess the degree of adherence of intensive care teams to extubation recommendations based on quantitative measurements of the degree of neuromuscular junction block
22 Secondary objectives Quantify NMBA doses used duration of action duration of recovery
3 Methodology of the clinical research project
In this study we will systematically check the degree of curarization of cardiac surgery patients up to the time of extubation Prior to surgery all patients will have an explanation of the protocol and will give written informed consent for the use of their data Patient management is at the discretion of the anaesthetist in charge and will not be altered in any way by the protocol All drugs used will be standard of care At the end of the procedure one of the investigators will stay with the patient in intensive care and measure the degree of neuromuscular blockade with a curameter used as standard in clinical routine at Erasme Hospital TOFScan IdMed Marseille France All measurements will be made in accordance with Good clinical research practice GCRP in pharmacodynamic studies of neuromuscular blocking agents III This measurement will be carried out continuously until the patient is extubated or 100 neuromuscular transmission has been recovered ICU staff in charge of the patient will be blinded to the measurements done by the investigators Intensive care physicians manage the patient according to the ICU standard of care If the patient represents a residual curarization at the time of extubation the investigators will inform the ICU staff in order to avoid endangering the patient
No intervention will be made with regard to the anesthesia and post-operative monitoring protocol all medications and interventions will be considered standard of care and will be left to the discretion of the anesthesiologist and ICU team in charge
4 Design of the clinical research project
This is a prospective observational study
5 Participants
All patients undergoing cardiac surgery at Hôpital Érasme between October 1 2024 and May 31 2025
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None