Cataract
Conditions
Keywords
propofol, dexmedetomidine, cataract, respiratory, blood pressure, Cataract surgery
Brief summary
The use of dexmedetomidine in cataract surgery is still limited and to date only one study has examined anesthetic technique in this patient population. This pilot study will therefore compare the use of dexmedetomidine and propofol in subjects undergoing cataract surgery. The primary endpoint will be based on simple cardiorespiratory measures often associated with complications from sedation as well as assessment of the achieved sedation by the attending anesthesiologist and surgeon.
Interventions
DRUGdexmedetomidine
Propofol or dexmedetomidine infusion will be started according to the randomized treatment allocation. The propofol group will receive a bolus of 2mg midazolam and 100mcg fentanyl and then continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved. The dexmedetomidine group will receive a bolus of dexmedetomidine 1mcg/kg for 10 minutes and then a continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.
DRUGPropofol
continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved
DRUGDexemedetomidine
continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Normal renal function 2. No chronic use of narcotics 3. ASA PS1-3 4. Males or females age 18 or older
Exclusion criteria
1. Liver disease (Child Pugh classification 1-3) 2. History of chronic use of sedatives, narcotics, alcohol or illicit drugs or allergy to any the study medications 3. History of 1st and 2nd degree heart block (not paced) 4. Any patient with EF \< 30% 5. Patients with active seizure history 6. Pregnant patients (women of child bearing potential will have a preoperative pregnancy test as is standard of practice)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery. | 1 day |
Countries
United States
Outcome results
None listed