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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02771912

Acronym

CATARSIS

Enrollment

Registered

2016-05-13

Start date

2016-07-31

Completion date

2017-02-21

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

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.

Interventions

DRUGPropofol

Propofol and excipients

DRUGPlacebo

Qualitative composition of Propofol lipuro 2% excipients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of self administered bolus	One day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026