Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05487742
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2022-08-02
Brief Title:
Neuroprotective Effect of Dexomitomidine
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Evaluation of Neuroprotective Effect of Dexmedetomidine in Traumatic Brain Injury
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
None
Brief Summary:
patient wih mild to moderate traumatic brain injury in ICU will be randomisly distributed into two groups Group I control group Patients of this group receive placebo infusion for 72 hours Group II DEX group Patients of this group receive 05 ugkghr dexmedetomidine continuous infusion for 72 hour Patient demographics including age sex weight primary diagnosis Acute Physiology and Chronic Health Evaluation APACHE II score and postresuscitation Glasgow Coma Scale GCS score will be collected CBF will be measured at pre-sedation and after cessation of sedation dexmedetomidine administration The CMRe and CMReCBF will also be calculated Measurements of blood gas analysis and haemodynamic parameters systolic blood pressure SBP diastolic blood pressure DBP MAP and heart rate HR will be collected at pre-sedation and after cessation of sedation dexmedetomidine administration
Detailed Description:
Assessment will be done for the patients by taking careful medical history for any medical disorder therapeutic anticoagulant allergy to chemical compounds or addiction problems and performing trauma survey check up chest x-ray abdomen US CT brain for documentation of injury with general and physical examination for CNS assessement of GCS chest heart abdomen and peripheral limbs for any abnormality Then routine and relative investigations will be carried out such as complete blood picture renal and liver function tests coagulation tests and random blood sugar
all patients will be monitored with five- lead ECG non-invasive blood pressure pulse oximetry and end tidal CO2 Then a 20 gauge IV cannula will be inserted into a peripheral upper extremity vein for drug administration and DEX group patients received 05 ug kghr dexmedetomidine continuous infusion for 72 hour Ephedrine will be administrated to maintain the MAP at the pre-sedation level if BP decrease 20 from baseline BP and atropine if pulse decrease below 50 bm No extra sedatives other vasoactive drugs or volume resuscitation will be used during sedation Patient demographics including age sex weight primary diagnosis Acute Physiology and Chronic Health Evaluation APACHE II score and postresuscitation Glasgow Coma Scale GCS score will be collected CBF will be measured at pre-sedation and after cessation of sedation dexmedetomidine administration The CMRe and CMReCBF will also be calculated Measurements of blood gas analysis and haemodynamic parameters systolic blood pressure SBP diastolic blood pressure DBP MAP and heart rate HR will be collected at pre-sedation and after cessation of sedation dexmedetomidine administration
CBF measurement
CBF will be evaluated in the extra-cranial internal carotid artery ICA and vertebral artery VA using a spectral Doppler ultrasound technique Briefly the procedure will be performed with the patient in the supine position with a 75-MHz linear array transducer of a colour coded ultrasound system The patients head will slightly be elevated and turned to the contralateral side at a 25 - 40 angle for ICA measurements and at a 10 angle for VA measurements ICA will be assessed at the segment located 15 cm distal to the carotid bifurcation and VA will be measured between the transverse processes of the C4 and C5 vertebrae
Blood flow velocities will be obtained by keeping the Doppler insonation angle at a standard 60 Time averaged flow velocity TAV will be determined as the integral of the mean flow velocities of all moving particles passing the sample volume over 3-5 complete cardiac cycles The TAV peak systolic velocity end-diastolic velocity and inner vessel diameter d will be measured during the bilateral ICA and VA CBF measurements The intravascular flow volume FV of each artery will be calculated by the formula FV TAV x d2 x ℼ CBF will be calculated as the sum of bilateral ICA and VA flow volumes All ultrasound examinations will be performed in triplicate by the same radiologist using the same Doppler ultrasonography device
CBF reduction will be calculated as
pre-sedation CBF - during-sedation CBF pre-sedation CBF x100
CMRe evaluation
An 18-gauge venous catheter Arrow International Inc Bernville PA will be introduced into the right internal jugular vein at the level of the cricothyroid membrane and passed into the jugular bulb or at the base of the skull in a retrograde fashion with ultrasound guidance as previously described 12 Blood samples for jugular venous oxygen saturation SjvO2 measurements will be collected intermittently by aspiration at a rate of less than 15 ml min Arterial oxygen saturation SaO2 and partial pressure of carbon dioxide PaCO2 were assessed in blood samples taken from the femoral artery The CMRe and oxygen extraction ratio OER were calculated as follows
CMRe CBFx SaO2ml_1 _ SjvO2ml_1 relative units
OER SaO2 _ SjvO2SaO2 The CMRe CBF ratio was also determined at each time point The reduction in CMRe was calculated using the method described above 80 Patients will be randomly classified using sealed envelope into two equal groups each of 40 patients Group I control group Patients of this group receive placebo infusion for 72 hours Group II DEX group Patients of this group receive 05 ugkghr dexmedetomidine continuous infusion for 72 hour
all patients will be monitored with five- lead ECG non-invasive blood pressure pulse oximetry and end tidal CO2 Then a 20 gauge IV cannula will be inserted into a peripheral upper extremity vein for drug administration and DEX group patients received 05 ug kghr dexmedetomidine continuous infusion for 72 hour Ephedrine will be administrated to maintain the MAP at the pre-sedation level if BP decrease 20 from baseline BP and atropine if pulse decrease below 50 bm No extra sedatives other vasoactive drugs or volume resuscitation will be used during sedation Patient demographics including age sex weight primary diagnosis Acute Physiology and Chronic Health Evaluation APACHE II score and postresuscitation Glasgow Coma Scale GCS score will be collected CBF will be measured at pre-sedation and after cessation of sedation dexmedetomidine administration The CMRe and CMReCBF will also be calculated Measurements of blood gas analysis and haemodynamic parameters systolic blood pressure SBP diastolic blood pressure DBP MAP and heart rate HR will be collected at pre-sedation and after cessation of sedation dexmedetomidine administration
CBF measurement
CBF will be evaluated in the extra-cranial internal carotid artery ICA and vertebral artery VA using a spectral Doppler ultrasound technique Briefly the procedure will be performed with the patient in the supine position with a 75-MHz linear array transducer of a colour coded ultrasound system The patients head will slightly be elevated and turned to the contralateral side at a 25 - 40 angle for ICA measurements and at a 10 angle for VA measurements ICA will be assessed at the segment located 15 cm distal to the carotid bifurcation and VA will be measured between the transverse processes of the C4 and C5 vertebrae
Blood flow velocities will be obtained by keeping the Doppler insonation angle at a standard 60 Time averaged flow velocity TAV will be determined as the integral of the mean flow velocities of all moving particles passing the sample volume over 3-5 complete cardiac cycles The TAV peak systolic velocity end-diastolic velocity and inner vessel diameter d will be measured during the bilateral ICA and VA CBF measurements The intravascular flow volume FV of each artery will be calculated by the formula FV TAV x d2 x ℼ CBF will be calculated as the sum of bilateral ICA and VA flow volumes All ultrasound examinations will be performed in triplicate by the same radiologist using the same Doppler ultrasonography device
CBF reduction will be calculated as
pre-sedation CBF - during-sedation CBF pre-sedation CBF x100
CMRe evaluation
An 18-gauge venous catheter Arrow International Inc Bernville PA will be introduced into the right internal jugular vein at the level of the cricothyroid membrane and passed into the jugular bulb or at the base of the skull in a retrograde fashion with ultrasound guidance as previously described 12 Blood samples for jugular venous oxygen saturation SjvO2 measurements will be collected intermittently by aspiration at a rate of less than 15 ml min Arterial oxygen saturation SaO2 and partial pressure of carbon dioxide PaCO2 were assessed in blood samples taken from the femoral artery The CMRe and oxygen extraction ratio OER were calculated as follows
CMRe CBFx SaO2ml_1 _ SjvO2ml_1 relative units
OER SaO2 _ SjvO2SaO2 The CMRe CBF ratio was also determined at each time point The reduction in CMRe was calculated using the method described above 80 Patients will be randomly classified using sealed envelope into two equal groups each of 40 patients Group I control group Patients of this group receive placebo infusion for 72 hours Group II DEX group Patients of this group receive 05 ugkghr dexmedetomidine continuous infusion for 72 hour
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?:
False
Is an FDA AA801 Violation?:
None