Patient-controlled Sedation With Propofol During Cataract Surgery Under Topical Anesthesia

• Status: Completed
• Trial end date: 2017-02-21
• Target enrollment: 0
• Participant gender: All

Summary

Controversies exist about the use of propofol in sedation of patients for cataract surgery. This prospective randomised double-blind study evaluates the efficacy of patient-controlled sedation compared with placebo using the same device.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Treatments: Propofol; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Patients should be operated of cataract under topical anesthesia

Exclusion Criteria:

• Contra-indication to sedation

• Complicated cataract

• Hypersensitivity to propofol, known or suspected hypersensitivity to egg phospholipid, soybean or peanut protein

• State of acute shock, severe dyslipidemia, severe liver failure, serious bleeding disorders

• Comprehension and language impairment

• Written and signed informed consent by the patient to participate in the study