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

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Drug: Placebo; Drug: Propofol

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02771912

ILC_2016_5

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Propofol

Experimental group

Description:

Infusion containing Propofol lipuro® 2% at a concentration of 2 mg/ml (100 ml of 5% glucose at which is removed 20 ml replaced with 20 ml of Propofol lipuro® 2 %). Self administration of propofol via patient-controlled sedation pump (ambIT pump) : bolus of 0.125 ml/kg of the solution (0.25 mg/kg propofol) with a programmed lock-out period of 3 minutes. Maximal dose of propofol : 1,25 mg/kg corresponding to 5mg/kg/h.

Treatment:

Drug: Propofol

Intralipid

Placebo Comparator group

Description:

Infusion containing Intralipid® (100 ml of 5% glucose at which is removed 20 ml replaced with 20 ml of Intralipid® 20%) to obtain an identical aspect to that of propofol infusion. Self administration via patient-controlled sedation pump (ambIT pump) : bolus of 0.125 ml/kg of the solution with a programmed lock-out period of 3 minutes.

Treatment:

Drug: Placebo