Dexmedetomidine vs. Propofol for Cataract Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

Conditions
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Cataract

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: Propofol
* Drug: Dexemedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal renal function No chronic use of narcotics ASA PS1-3 Males or females age 18 or older Exclusion Criteria: Liver disease (Child Pugh classification 1-3) History of chronic use of sedatives, narcotics, alcohol or illicit drugs or allergy to any the study medications History of 1st and 2nd degree heart block (not paced) Any patient with EF < 30% Patients with active seizure history Pregnant patients (women of child bearing potential will have a preoperative pregnancy test as is standard of practice)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br> | Drug: Propofol<br>* continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved<br>|
| Experimental: Dexmedetomidine<br> | Drug: dexmedetomidine<br>* 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.<br>Drug: Dexemedetomidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery. |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, dexmedetomidine, cataract, respiratory, blood pressure, Cataract surgery