The investigators would like to determine if using Dexmedetomidine alone or in a reduced dose can prevent or reduce the incidence of adverse effects, while providing adequate sedation, and respiratory stability as compared to propofol.
Alpha2 adrenergic receptor agonist have been used increasingly as a new armamentarium to provide sedative/hypnotic, analgesic, anxiolytic and sympatholytic effects in the perioperative settings. Dexmedetomidine, a selective and specific alpha2- adrenoceptor agonist has unique properties that makes it an almost ideal sedative drug for monitored anesthesia care in procedures under local or regional block. Unlike other drugs use for sedation, dexmedetomidine induces sedation that is similar to natural sleep (readily arousable) without causing respiratory depression. It attenuates the stress-induced sympathoadrenal response seen with laryngoscopy and intubation. It has anesthetic and opioid sparing effects, hence it may be a useful adjunct to general anesthesia and monitored anesthesia care in patients susceptible to narcotic induced respiratory depression. Another unique property of dexmedetomidine is that its sedative effect is reversible with Atipamezole. A previous study wherein dexmedetomidine has been used in procedures under local and regional block had shown that it provides effective sedation and better operating condition without significant respiratory depression. As a supplement to general anesthesia, it has been shown to provide stable hemodynamics. However, it is associated with some adverse events such as hypertension, hypotension and bradycardia, these commonly occur during bolus administration of the recommended dose of 1ug/kg. Post-operatively it can cause nausea and vomiting. Vitreoretinal surgery requires either an injection of local anesthetic within the muscle cone (retrobulbar block),or into the periorbital space (peribulbar block). This can be done individually or in combination. This surgery can also be done under a safer technique of retrobulbar block that is given using a sub-tenon's approach through a snip peritomy; a blunt cannula can be used with this technique mitigating the complications of retrobulbar hemorrhage or inadvertent injection into the optic nerve sheath or perforation of the globe using a sharp needle. The anesthetic goal is to provide an immobile and uncongested operative field. Hemodynamic stability of the patient is also important since some patients that require this procedure are elderly with co-morbid conditions such as hypertension, diabetes mellitus and Coronary Artery Disease (CAD). In our study we would like to investigate if Dexmedetomidine alone and in a reduced dose can prevent or reduce the incidence of adverse effects, provide hemodynamic and respiratory stability, provide adequate sedation with patient and surgeon satisfaction and compare it with Propofol. Objectives: Primary: 1. Adequate sedation 2. Hemodynamic and respiratory stability intraoperatively Secondary: 1. surgeon satisfaction 2. Time to achieved " street fitness " status 3. subject satisfaction 4. Hemodynamic stability in PACU
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug
propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
UMDNJ-University Hospital
Newark, New Jersey, United States
University Hospital
Newark, New Jersey, United States
Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)
Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.
Time frame: Intraoperative up to 120 min
Intraoperative Hemodynamic Stability
systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm
Time frame: Intraoperative up to 120 min
Intraoperative Respiratory Stability
respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm
Time frame: Intraoperative up to 120 min
Intraoperative Heart Rate Stability
Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm
Time frame: Intraoperative up to 120 min
Time to Achieve "Street Fitness"
Subjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.
Time frame: for 2 hours post-operatively in Post Anesthesia Care unit
Surgeon Satisfaction for Adequate Sedation
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1=very poor, 2=poor,3=fair, 4=good, 5=excellent
Time frame: at 10 minutes into the procedure
Surgeon Satisfaction for Adequate Sedation at Completion of Procedure
surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent
Time frame: immediately following the completion of the procedure up to one hour
Patient Satisfaction
1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent
Time frame: measured prior to discharge up to 2 hours
Post Operative Hemodynamic Stability
blood pressure documented at 30 minute intervals in PACU up to 120 min
Time frame: 2 hours in PACU
Hemodynamic Stability Post Operatively in PACU
heart rate recorded at 30 min intervals in PACU up to 120 min
Time frame: PACU to 2 hours post op