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

F

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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