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NCT02771912 Clinical Trial

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

Sedation Clinical Trial

— CATARSIS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02771912
Other study ID # ILC_2016_5
Secondary ID
Status Completed
Phase Phase 4
First received May 12, 2016
Last updated July 26, 2017
Start date July 2016
Est. completion date February 21, 2017

Study information
Verified date July 2017
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 21, 2017
Est. primary completion date February 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
Propofol and excipients
• Placebo
Qualitative composition of Propofol lipuro 2% excipients

Locations
Country Name City State
France Fondation Ophtalmique Adolphe de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of self administered bolus One day
See also
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Completed NCT06449365 - Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy Phase 4
Completed NCT02171910 - Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Phase 4
Completed NCT02211118 - Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD Phase 4
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