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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:
Secondary:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min |
|
| dexmedetomidine infusion | Experimental | Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine infusion | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | Intraoperative up to 120 min |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | for 2 hours post-operatively in Post Anesthesia Care unit |
| Surgeon Satisfaction for Adequate Sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anuradha Patel, MD | Rutgers /NJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMDNJ-University Hospital | Newark | New Jersey | 07102 | United States | ||
| University Hospital |
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One subject withdrew consent prior to group assignment. One subject surgery was cancelled
Subjects were recruited the morning of surgery in the Same Day Surgery Suite
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min |
| FG001 | Dexmedetomidine Infusion | Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min |
| BG001 | Dexmedetomidine Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Inter-Quartile Range | units on a scale | Intraoperative up to 120 min |
|
Heart rate, blood pressure, pulse oximetry are collected for all patients undergoing sedation or anesthesia for the entire time they are in the operating room which was between 1-2 hrs. Additionally heart rate, blood pressure, pulse oximetry were monitored for 2 hours in the Post Anesthesia Care Unit where patients are placed immediately following the procedure.
Change in ECG, T wave inversion was noted on the cardiac monitor in the operating room, no intervention was required and the surgery continued without incident. A cardiology consult was called and the subject was admitted for observation. A myocardial perfusion test demonstrated a fixed deficit in the left ventricle, the Ejection fraction was 55% and serial Troponin levels were<0.2, well below threshold for evidence of myocardial injury
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol | propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| T wave inversion on EKG | Cardiac disorders | Systematic Assessment |
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Termination of study due to difficulty recruiting subjects who fit the study criteria.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anuradha Patel, MD | Rutgers New Jersey Medical School | 973 972-1886 | patelan@njms.rutgers.edu |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| propofol | Drug | propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min |
|
|
1=very poor, 2=poor,3=fair, 4=good, 5=excellent |
| 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 | 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 | 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 | 2 hours in PACU |
| Hemodynamic Stability Post Operatively in PACU | heart rate recorded at 30 min intervals in PACU up to 120 min | PACU to 2 hours post op |
| Newark |
| New Jersey |
| 07102 |
| United States |
Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.
Dexmedetomidine infusion: 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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| total participants | Number | participants |
|
| OG001 |
| BIS Scores in Dexmedetomidine Infusion Group |
Subject will receive a 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. Dexmedetomidine infusion: 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 |
| OG002 | UMSS Scores in Propofol Infusion Group | Propofol medication administered as described in BIS group/Propofol group |
| OG003 | UMSS in Dexmedetomidine Infusion Group | subject received medication as described in BIS/dexmedetomidine |
|
|
|
| Secondary | 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. | Subjects meet criteria for discharge based upon the assessment from a professional independent of the study | Posted | Mean | Inter-Quartile Range | minutes | for 2 hours post-operatively in Post Anesthesia Care unit |
|
|
|
| Primary | Intraoperative Hemodynamic Stability | systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm | Posted | Mean | Inter-Quartile Range | mm/Hg | Intraoperative up to 120 min |
|
|
|
| Primary | 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 | Posted | Mean | Full Range | breaths per minute | Intraoperative up to 120 min |
|
|
|
| Primary | Intraoperative Heart Rate Stability | Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm | Posted | Mean | Full Range | beats per minute | Intraoperative up to 120 min |
|
|
|
| Secondary | Surgeon Satisfaction for Adequate Sedation | 1=very poor, 2=poor,3=fair, 4=good, 5=excellent | Posted | Mean | Full Range | units on a scale | at 10 minutes into the procedure |
|
|
|
| Secondary | 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 | Posted | Mean | Full Range | units on a scale | immediately following the completion of the procedure up to one hour |
|
|
|
| Secondary | Patient Satisfaction | 1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent | Posted | Mean | Full Range | units on a scale | measured prior to discharge up to 2 hours |
|
|
|
| Secondary | Post Operative Hemodynamic Stability | blood pressure documented at 30 minute intervals in PACU up to 120 min | Posted | Mean | Inter-Quartile Range | mmHg | 2 hours in PACU |
|
|
|
| Secondary | Hemodynamic Stability Post Operatively in PACU | heart rate recorded at 30 min intervals in PACU up to 120 min | Posted | Mean | Inter-Quartile Range | beats per minute | PACU to 2 hours post op |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Dexmedetomidine Infusion | Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: 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 | 1 | 37 | 0 | 37 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |