Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464490
Status:
TERMINATED
Last Update Posted:
2014-10-31
First Post:
2007-04-19
Brief Title:
Use of Dexmedetomidine to Facilitate Extubation in Surgical ICU Patients Who Failed Previous Weaning Attempts
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Prospective Randomized Controlled Study on the Use of Dexmedetomidine to Facilitate Extubation in Surgical Intensive-Care-Unit Patients Who Failed Previous Weaning Attempts
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of eligible participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mechanical ventilation commonly is associated with patient agitation requiring sedation to alleviate discomfort and reduce excessive central respiratory drive Upon recovery from acute respiratory failure sedation is reduced to facilitate the withdrawal of ventilatory support In some patients abrupt reduction in sedation provokes severe agitation that causes catecholamine release resulting in severe hypertension tachycardia and tachypnea This requires increased sedation to bring hemodynamic and respiratory function under control
Dexmedetomidine is an alpha-2 receptor agonist with both sedative and analgesic properties that allows for the reduction in the anesthetic and analgesic requirements in the perioperative setting In addition to its sedative effects alpha-2 receptor stimulation in the central nervous system inhibits sympathetic activity and reduces plasma epinephrine and norepinephrine levels thereby lowering both arterial blood pressure and heart rate Because alpha-2 receptor stimulation does not cause respiratory depression dexmedetomidine may facilitate the transition to unassisted breathing in profoundly agitated patients The investigators will prospectively evaluate dexmedetomidine in 30 patients who could not be extubated because of agitation with hemodynamic instability and tachypnea
The purpose of this study is to test if a larger prospective randomized controlled pilot study can show that dexmedetomidine facilitates weaning and extubation in patients who have failed previous attempts because of agitation and hyperdynamic cardiopulmonary response
Dexmedetomidine is an alpha-2 receptor agonist with both sedative and analgesic properties that allows for the reduction in the anesthetic and analgesic requirements in the perioperative setting In addition to its sedative effects alpha-2 receptor stimulation in the central nervous system inhibits sympathetic activity and reduces plasma epinephrine and norepinephrine levels thereby lowering both arterial blood pressure and heart rate Because alpha-2 receptor stimulation does not cause respiratory depression dexmedetomidine may facilitate the transition to unassisted breathing in profoundly agitated patients The investigators will prospectively evaluate dexmedetomidine in 30 patients who could not be extubated because of agitation with hemodynamic instability and tachypnea
The purpose of this study is to test if a larger prospective randomized controlled pilot study can show that dexmedetomidine facilitates weaning and extubation in patients who have failed previous attempts because of agitation and hyperdynamic cardiopulmonary response
Detailed Description:
Sixty patients who are admitted to the surgical intensive care unit ICU at San Francisco General Hospital will be referred to the investigators for enrollment into a prospective unblinded randomized study of dexmedetomidine Each patient will be considered by the critical care team as a suitable candidate for weaning and extubation based on inclusion exclusion criteria Pregnant patients will not be enrolled and this will be determined by a negative urine or serum pregnancy test from admission If none is available a pregnancy test will be performed prior to enrollment Patients considered difficult to wean will be based on the following criteria
Eligible patients will be randomized to either the control arm or the dexmedetomidine arm in a 11 ratio by using sealed envelopes
Patient randomized to the control arm will be extubated per standard hospital protocol This arm of the study will be observational and these patients will be extubated by the attending physician for that patient whenever they are hemodynamically stable enough to tolerate another weaning trial The study team will collect the same data points for the control arm as in the dexmedetomidine arm This includes ABGs heart rate mean blood pressure respiratory rate and RASS scores see description below of data points and collection time points Arterial blood gases will be drawn for the control arm of the study
Patients on the dexmedetomidine arm will be started on dexmedetomidine at either 05 mcgkghr or 07 mcgkghr 1 hour prior to extubation The drug calculation was based upon an average taken between the patients measured and predicted body weight Background sedation will be generally facilitated with lorazepam midazolam or propofol while analgesia will be maintained with either fentanyl or hydromorphine After starting dexmedetomidine background sedation and analgesia will be titrated down and discontinued if possible Analgesia levels also will be reduced if tolerated Dexmedetomidine will be titrated according to blood pressure RASS and heart rate response and the dose will be lowered only after sedation is discontinued or markedly reduced Aerosolized lidocaine 20 mg therapy will be initiated prior to the weaning trial to prevent excessive coughing in all patients
Shortly after the dexmedetomidine infusion is started PSV will be commenced at 5 cm H2O above 5 cm H2O of continuous positive airway pressure CPAP Patients will be weaned to CPAP and evaluated for extubation
1 Arterial blood gases will be obtained in all patients with an arterial line at three points in time just prior to dexmedetomidine infusion during the CPAP trial and approximately 30 minutes after extubation
3 Heart rate mean blood pressure RASS and respiratory rate will be collected at fifteen minute intervals 1 hour prior to dexmedetomidine infusion during the 1 hour infusion of dexmedetomidine prior to the extubation then 5 15 30 45 60 90 and 120 minutes after extubation for a total of 4 hours of data collection
Eligible patients will be randomized to either the control arm or the dexmedetomidine arm in a 11 ratio by using sealed envelopes
Patient randomized to the control arm will be extubated per standard hospital protocol This arm of the study will be observational and these patients will be extubated by the attending physician for that patient whenever they are hemodynamically stable enough to tolerate another weaning trial The study team will collect the same data points for the control arm as in the dexmedetomidine arm This includes ABGs heart rate mean blood pressure respiratory rate and RASS scores see description below of data points and collection time points Arterial blood gases will be drawn for the control arm of the study
Patients on the dexmedetomidine arm will be started on dexmedetomidine at either 05 mcgkghr or 07 mcgkghr 1 hour prior to extubation The drug calculation was based upon an average taken between the patients measured and predicted body weight Background sedation will be generally facilitated with lorazepam midazolam or propofol while analgesia will be maintained with either fentanyl or hydromorphine After starting dexmedetomidine background sedation and analgesia will be titrated down and discontinued if possible Analgesia levels also will be reduced if tolerated Dexmedetomidine will be titrated according to blood pressure RASS and heart rate response and the dose will be lowered only after sedation is discontinued or markedly reduced Aerosolized lidocaine 20 mg therapy will be initiated prior to the weaning trial to prevent excessive coughing in all patients
Shortly after the dexmedetomidine infusion is started PSV will be commenced at 5 cm H2O above 5 cm H2O of continuous positive airway pressure CPAP Patients will be weaned to CPAP and evaluated for extubation
1 Arterial blood gases will be obtained in all patients with an arterial line at three points in time just prior to dexmedetomidine infusion during the CPAP trial and approximately 30 minutes after extubation
3 Heart rate mean blood pressure RASS and respiratory rate will be collected at fifteen minute intervals 1 hour prior to dexmedetomidine infusion during the 1 hour infusion of dexmedetomidine prior to the extubation then 5 15 30 45 60 90 and 120 minutes after extubation for a total of 4 hours of data collection
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