A Phase 4 interventional study of Dexmedetomidine infusion and propofol in Retinal Detachment, sponsored by Rutgers, The State University of New Jersey. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by Rutgers, The State University of New Jersey · Phase 4, Interventional, and Treatment
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:
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
This study's enrollment of 78 is above the median of 50 across 136 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
Drug: propofol
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.
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
Also known as: Precedex infusion
propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
Also known as: Diprivan
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
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
Subjects were recruited the morning of surgery in the Same Day Surgery Suite
| Milestone | Propofol | Dexmedetomidine Infusion |
|---|---|---|
| Started | 39 | 38 |
| Completed | 39 | 37 |
| Not completed | 0 | 1 |
| Withdrew: Surgery cancelled | 0 | 1 |
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.
| units on a scale | BIS Scores in Propofol Infusion Group | BIS Scores in Dexmedetomidine Infusion Group | UMSS Scores in Propofol Infusion Group | UMSS in Dexmedetomidine Infusion Group |
|---|---|---|---|---|
| Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS) | 84.8 (77.5 to 92.1) | 88 (78 to 94) | .90 (.47 to 1.33) | .94 (.43 to 1.45) |
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.
| minutes | Propofol | Dexmedetomidine Infusion |
|---|---|---|
| Time to Achieve "Street Fitness" | 81 (54 to 108) | 85 (49.8 to 120) |
systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm
| mm/Hg | Propofol Group -Mean Systolic Blood Pressure | Dexmedetomidine Group-mean Systolic Blood Pressure | Propofol Group- Mean Diastolic Blood Pressure | Dexmedetomidine Group- Mean Diastolic Blood Pressure |
|---|---|---|---|---|
| Intraoperative Hemodynamic Stability | 124.9 (108.7 to 141.1) | 114.6 (100.1 to 129.1) | 73.6 (61.1 to 86.1) | 66.2 (55.4 to 77.0) |
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
| breaths per minute | Propofol Group | Dexmedetomidine Group |
|---|---|---|
| Intraoperative Respiratory Stability | 17 (12 to 22) | 12 (8 to 16) |
Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm
| beats per minute | Propofol Group | Dexmedetomidine |
|---|---|---|
| Intraoperative Heart Rate Stability | 71 (58 to 84) | 64 (49 to 80) |
1=very poor, 2=poor,3=fair, 4=good, 5=excellent
| units on a scale | Propofol Group | Dexmedetomidine Group |
|---|---|---|
| Surgeon Satisfaction for Adequate Sedation | 4.62 (3 to 5) | 4.97 (3 to 5) |
surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent
| units on a scale | Propofol Group | Dexmedetomidine Group |
|---|---|---|
| Surgeon Satisfaction for Adequate Sedation at Completion of Procedure | 4.77 (3 to 5) | 4.89 (3 to 5) |
1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent
| units on a scale | Propofol | Dexmedetomidine Group |
|---|---|---|
| Patient Satisfaction | 4.61 (3 to 5) | 4.43 (3 to 5) |
blood pressure documented at 30 minute intervals in PACU up to 120 min
| mmHg | Propofol Group | Dexmedetomidine Group | Propofol | Dexmedetomidine |
|---|---|---|---|---|
| Post Operative Hemodynamic Stability | 124.9 (108.7 to 141.1) | 114.6 (100.1 to 129.1) | 73.6 (61.1 to 86.1) | 66.2 (55.4 to 77) |
heart rate recorded at 30 min intervals in PACU up to 120 min
| beats per minute | Propofol Group | Dexmedetomidine |
|---|---|---|
| Hemodynamic Stability Post Operatively in PACU | 74.1 (72 to 77) | 72 (71 to 73) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propofol | — | 0/39 (0%) | 0/39 (0%) |
| Dexmedetomidine Infusion | — | 1/37 (2.7%) | 0/37 (0%) |
| Event | Propofol | Dexmedetomidine Infusion |
|---|---|---|
| T wave inversion on EKGCardiac disorders | 0/39 | 1/37 |
| Age, Continuous(years) | Propofol | Dexmedetomidine Infusion | Total |
|---|---|---|---|
| Mean | 40 (40 to 60) | 52 (42.8 to 61.2) | 46 (40 to 61.2) |
| Sex: Female, Male(Participants) | Propofol | Dexmedetomidine Infusion | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 28 | 25 | 53 |
| total participants(participants) | Propofol | Dexmedetomidine Infusion | Total |
|---|---|---|---|
| Number | 39 | 37 | 76 |
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Rutgers, The State University of New Jersey