Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311604
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-08-21
Brief Title:
Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Evaluation of the Safety of Inhaled Sedation With Isoflurane in Patients With Severe Traumatic Brain Injury
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IsoSAFE
Brief Summary:
Intensive care management of patient with severe traumatic brain injury TBI includes deep and prolonged sedation with intravenous hypnotics propofol midazolam ketamine in combination with opioids to prevent andor treat episodes of intracranial hypertension However some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation This situation leads to a failure in controlling intracranial pressure ICP andor to the risk of adverse effects due to high-dose sedatives haemodynamic instability prolonged mechanical ventilation neuromyopathy delirium withdrawal syndrome
Halogenated agents Isoflurane Sevoflurane are a class of hypnotics routinely used in the operating room However doses used in surgical patients 1 Minimal Alveolar Concentration MAC are not suitable in neuro-intensive care unit ICU patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage hence the risk of high ICP and compromised cerebral perfusion pressure
The use of halogenated agents has been recently possible in the ICU through dedicated medical devices Sedaconda ACD Mirus Recommended dosage are lower in the ICU ie 03-07 MAC because of their association with intravenous hypnotics and the absence of surgical stimuli Several clinical studies in general ICUs showed improved sedation quality reduced duration of mechanical ventilation faster arousal and shorter extubation time and lower costs in halogenated group compared with control group receiving midazolam or propofol At low doses the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature In addition beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents However there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population
The investigator hypothesise that 07 MAC Isoflurane can be administered in this population without deleterious effect on ICP
Halogenated agents Isoflurane Sevoflurane are a class of hypnotics routinely used in the operating room However doses used in surgical patients 1 Minimal Alveolar Concentration MAC are not suitable in neuro-intensive care unit ICU patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage hence the risk of high ICP and compromised cerebral perfusion pressure
The use of halogenated agents has been recently possible in the ICU through dedicated medical devices Sedaconda ACD Mirus Recommended dosage are lower in the ICU ie 03-07 MAC because of their association with intravenous hypnotics and the absence of surgical stimuli Several clinical studies in general ICUs showed improved sedation quality reduced duration of mechanical ventilation faster arousal and shorter extubation time and lower costs in halogenated group compared with control group receiving midazolam or propofol At low doses the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature In addition beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents However there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population
The investigator hypothesise that 07 MAC Isoflurane can be administered in this population without deleterious effect on ICP
Detailed Description:
Intensive care management of patients with severe neurological injury regularly involves deep and prolonged sedation with intravenous hypnotics propofol midazolam ketamine in combination with morphine with the aim of preventing andor treating episodes of intracranial hypertension ICHT However the tachyphylaxis associated with intravenous hypnotics requires a continuous increase in the doses administered to maintain the same level of sedation or even a combination of several pharmacological classes This progressive tolerance to hypnotics may result in the failure of the sedation strategy for certain neuro-injured patients andor expose them to the undesirable effects of high doses of intravenous hypnotics haemodynamic instability longer periods of mechanical ventilation neuromyopathy mental confusion and withdrawal syndrome
Inhaled halogens are a class of hypnotics used daily in the operating theatre to maintain anaesthesia At the doses used in anaesthesia 1 MAC - Minimal Alveolar Concentration they are contraindicated in neuro-injured patients at risk of HTIC because of their cerebral vasodilatory effects which can lead to an increase in intracranial pressure ICP and compromise cerebral perfusion Halogens Isoflurane Sevoflurane can be used in intensive care with appropriate medical devices Isoconda Mirus They are used at more moderate doses 1 MAC because they are combined with intravenous hypnotics and because there is no surgical stimulus Several clinical studies in general intensive care have shown improved sedation quality reduced duration of mechanical ventilation quicker awakening and shorter time to tracheal extubation and lower costs in the group treated with a halogenated agent compared with the control group receiving midazolam or propofol At these low concentrations the effects on ICP and intracerebral haemodynamics are much less marked according to the studies published on this subject In addition beneficial effects on the volume of cerebral ischaemia have been shown in animal models treated with halogenated agents However there is a need for a precise study of the benefit-risk ratio of using halogenated agents in neurological patients
The Anaesthesia and Intensive Care Unit at the CHUGA has been internationally recognised for many years in the management of sedation-analgesia in intensive care In connection with this the experience acquired by the CHUGAs neuro-resuscitation unit in brain monitoring will be used to explore in detail the effects of halogenated agents on intracerebral haemodynamics and intracranial pressure
the investigator hypothesise that the administration of Isoflurane at 07 MAC can be used in this population without deleterious effect on ICP
Inhaled halogens are a class of hypnotics used daily in the operating theatre to maintain anaesthesia At the doses used in anaesthesia 1 MAC - Minimal Alveolar Concentration they are contraindicated in neuro-injured patients at risk of HTIC because of their cerebral vasodilatory effects which can lead to an increase in intracranial pressure ICP and compromise cerebral perfusion Halogens Isoflurane Sevoflurane can be used in intensive care with appropriate medical devices Isoconda Mirus They are used at more moderate doses 1 MAC because they are combined with intravenous hypnotics and because there is no surgical stimulus Several clinical studies in general intensive care have shown improved sedation quality reduced duration of mechanical ventilation quicker awakening and shorter time to tracheal extubation and lower costs in the group treated with a halogenated agent compared with the control group receiving midazolam or propofol At these low concentrations the effects on ICP and intracerebral haemodynamics are much less marked according to the studies published on this subject In addition beneficial effects on the volume of cerebral ischaemia have been shown in animal models treated with halogenated agents However there is a need for a precise study of the benefit-risk ratio of using halogenated agents in neurological patients
The Anaesthesia and Intensive Care Unit at the CHUGA has been internationally recognised for many years in the management of sedation-analgesia in intensive care In connection with this the experience acquired by the CHUGAs neuro-resuscitation unit in brain monitoring will be used to explore in detail the effects of halogenated agents on intracerebral haemodynamics and intracranial pressure
the investigator hypothesise that the administration of Isoflurane at 07 MAC can be used in this population without deleterious effect on ICP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None