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OpenTrials
Completed

NCT Number: NCT02771912

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

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.

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Key information

Conditions

Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Propofol and excipients

Other names: Propofol lipuro 2%

Placebo

Drug

Qualitative composition of Propofol lipuro 2% excipients

Other names: Intralipid

Primary outcomes

  1. Number of self administered bolus

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: CATARSIS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 13, 2016
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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