Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2010 |
End Date: | July 2012 |
Dexmedetomidine vs Propofol TIVA and Interscalene Block for Shoulder Surgeries in a Beach Chair Sitting Position
The standard hospital procedure calls for the patient to undergo Interscalene block under
ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).
The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the
patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The
participant is then brought to the OR and prolonged sedation is initiated, randomly using
either Dexmedetomidine or Propofol.
The primary objective of the present study is to use Dexmedetomidine for sedation, and
compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for
this study.
Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and
reduced need for supplemental medication for sedation, compared to Propofol
ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).
The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the
patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The
participant is then brought to the OR and prolonged sedation is initiated, randomly using
either Dexmedetomidine or Propofol.
The primary objective of the present study is to use Dexmedetomidine for sedation, and
compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for
this study.
Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and
reduced need for supplemental medication for sedation, compared to Propofol
The anesthesia provided during shoulder surgery commonly uses a combination of regional and
intravenous (IV) anesthetic medications. The current drug of choice for IV sedation is
Propofol. Although. it is a good anesthetic, incidence of intermittent apnea makes the use
of it problematic in cases where the head of the patient is less accessible to the
anesthesiologist, as is in sitting beach char position. Dexmedetomidine is a FDA approved
drug, which has a very stable cardiovascular and respiratory profile. It has been
successfully used for Neurological and Vascular cases and in Intensive care units. The
primary objective of the present study is to use Dexmedetomidine for sedation, and compare
the outcomes with Propofol sedation. The investigators' will enroll 50 patients for this
study. Using a computer program the participants will be randomized into two equal groups to
receive either Dexmedetomidine or Propofol.
The standard hospital procedure calls for the patient to undergo Interscalene block under
ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).
The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the
patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The
participant is then brought to the OR and prolonged sedation is initiated, randomly using
either Dexmedetomidine or Propofol.
Dexmedetomidine infusion is initiated with a bolus of 1 mcg/kg is given over 10 min as
patient is being positioned, and the sedation is maintained with Dexmedetomidine at 0.7- 1.0
mcg/kg/hr during the surgery. Propofol infusion is started at 100mcg/kg/min, and maintained
with Propofol at 50-120mcg/kg/min, during the surgery.
In each group the investigators will record the incidence of respiratory depression/hypoxia,
hemodynamic stability, frequency of airway manipulation, cardiovascular effects, need for
anesthetic supplementation of Dexmedetomidine, post anesthesia care unit (PACU) discharge
time, the need for postoperative pain medication, post operative complications, like
nausea/vomiting.
Significant differences between the two groups will be evaluated using unpaired t-test for
numerical variables, and Chi-square test or Z test for categorical variables.
The investigators hypothesis is that Dexmedetomidine will cause fewer episodes of
intermittent apnea, and reduced need for supplemental medication for sedation, compared to
Propofol
intravenous (IV) anesthetic medications. The current drug of choice for IV sedation is
Propofol. Although. it is a good anesthetic, incidence of intermittent apnea makes the use
of it problematic in cases where the head of the patient is less accessible to the
anesthesiologist, as is in sitting beach char position. Dexmedetomidine is a FDA approved
drug, which has a very stable cardiovascular and respiratory profile. It has been
successfully used for Neurological and Vascular cases and in Intensive care units. The
primary objective of the present study is to use Dexmedetomidine for sedation, and compare
the outcomes with Propofol sedation. The investigators' will enroll 50 patients for this
study. Using a computer program the participants will be randomized into two equal groups to
receive either Dexmedetomidine or Propofol.
The standard hospital procedure calls for the patient to undergo Interscalene block under
ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).
The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the
patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The
participant is then brought to the OR and prolonged sedation is initiated, randomly using
either Dexmedetomidine or Propofol.
Dexmedetomidine infusion is initiated with a bolus of 1 mcg/kg is given over 10 min as
patient is being positioned, and the sedation is maintained with Dexmedetomidine at 0.7- 1.0
mcg/kg/hr during the surgery. Propofol infusion is started at 100mcg/kg/min, and maintained
with Propofol at 50-120mcg/kg/min, during the surgery.
In each group the investigators will record the incidence of respiratory depression/hypoxia,
hemodynamic stability, frequency of airway manipulation, cardiovascular effects, need for
anesthetic supplementation of Dexmedetomidine, post anesthesia care unit (PACU) discharge
time, the need for postoperative pain medication, post operative complications, like
nausea/vomiting.
Significant differences between the two groups will be evaluated using unpaired t-test for
numerical variables, and Chi-square test or Z test for categorical variables.
The investigators hypothesis is that Dexmedetomidine will cause fewer episodes of
intermittent apnea, and reduced need for supplemental medication for sedation, compared to
Propofol
Inclusion Criteria:
Participants scheduled for shoulder arthroscopies in the beach chair sitting position.
Participants who received a successful interscalene block.
Exclusion Criteria:
Failed interscalene block. Refusal to participate in the study. Allergy to the study
drugs. Participants that need a secure airway.
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