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

Primary Purpose

Sedation

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Propofol
Placebo
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondation Ophtalmique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propofol

Intralipid

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of self administered bolus

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
July 26, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02771912
Brief Title
Patient-controlled Sedation With Propofol During Cataract Surgery Under Topical Anesthesia
Acronym
CATARSIS
Official Title
Randomised Study of Propofol Versus Placebo for Sedation During Cataract Surgery Under Topical Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
February 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Experimental
Arm 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.
Arm Title
Intralipid
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol lipuro 2%
Intervention Description
Propofol and excipients
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Intralipid
Intervention Description
Qualitative composition of Propofol lipuro 2% excipients
Primary Outcome Measure Information:
Title
Number of self administered bolus
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Fondation Ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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