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

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ClinicalTrials.gov Identifier: NCT02771912
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.

Condition or disease Intervention/treatment Phase
Sedation Drug: Propofol Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Study of Propofol Versus Placebo for Sedation During Cataract Surgery Under Topical Anesthesia
Study Start Date : July 2016
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : February 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Cataract
Drug Information available for: Propofol

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 Name: 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 Name: Intralipid




Primary Outcome Measures :
  1. Number of self administered bolus [ Time Frame: One day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771912


Locations
France
Fondation Ophtalmique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02771912     History of Changes
Other Study ID Numbers: ILC_2016_5
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Propofol
Soybean oil, phospholipid emulsion
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions