Patient-controlled Sedation With Propofol During Cataract Surgery Under Topical Anesthesia (CATARSIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02771912|
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sedation||Drug: Propofol Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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.
Qualitative composition of Propofol lipuro 2% excipients
Other Name: Intralipid
- Number of self administered bolus [ Time Frame: One day ]
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
|Fondation Ophtalmique Adolphe de Rothschild|
|Paris, France, 75019|