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

Randomised Study of Propofol Versus Placebo for Sedation During Cataract Surgery Under Topical Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Sedation
• Intervention / Treatment: Drug: Propofol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation ophtalmique Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Propofol; 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.	Drug: Propofol; Propofol and excipients; Other Names: Propofol lipuro 2%
PLACEBO_COMPARATOR: Intralipid; 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.	Drug: Placebo; Qualitative composition of Propofol lipuro 2% excipients; Other Names: Intralipid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of self administered bolus	One day

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): February 21, 2017
• Study Completion (ACTUAL): February 21, 2017

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (ESTIMATE): May 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Propofol; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: ILC_2016_5