Dexmedetomidine vs. Propofol for Cataract Surgery

The Cooper Health System24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cataract

Interventions

dexmedetomidineDRUG

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.

PropofolDRUG

continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved

DexemedetomidineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cooper University Hospital

Camden, New Jersey, United States

Outcomes

Primary Outcomes

To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery.

Time frame: 1 day

Data from ClinicalTrials.gov

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