Dexmedetomidine Versus Propofol in Vitreoretinal Surgery
- Conditions
- Retinal Detachment
- Interventions
- Registration Number
- NCT01001429
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- American Society of Anesthesiologists rating of I-III
- good renal and liver function
- renal and hepatic insufficiency
- uncontrolled diabetes
- uncontrolled hypertension
- severe cardiac disease Class III or IV
- heart blocks
- chronic use of sedatives, narcotics, alcohol or illicit drugs
- allergy to either propofol or dexmedetomidine
- pregnancy or inability to tolerate technique of the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexmedetomidine infusion 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. Propofol propofol propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
- Primary Outcome Measures
Name Time Method Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS) Intraoperative up to 120 min 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 Hemodynamic Stability Intraoperative up to 120 min systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm
Intraoperative Respiratory Stability Intraoperative up to 120 min 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 Heart Rate Stability Intraoperative up to 120 min Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm
- Secondary Outcome Measures
Name Time Method Time to Achieve "Street Fitness" for 2 hours post-operatively in Post Anesthesia Care unit 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.
Surgeon Satisfaction for Adequate Sedation at 10 minutes into the procedure 1=very poor, 2=poor,3=fair, 4=good, 5=excellent
Surgeon Satisfaction for Adequate Sedation at Completion of Procedure immediately following the completion of the procedure up to one hour surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent
Patient Satisfaction measured prior to discharge up to 2 hours 1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent
Post Operative Hemodynamic Stability 2 hours in PACU blood pressure documented at 30 minute intervals in PACU up to 120 min
Hemodynamic Stability Post Operatively in PACU PACU to 2 hours post op heart rate recorded at 30 min intervals in PACU up to 120 min
Trial Locations
- Locations (2)
UMDNJ-University Hospital
🇺🇸Newark, New Jersey, United States
University Hospital
🇺🇸Newark, New Jersey, United States