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

NCT ID: NCT02771912

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-02-21

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.

Conditions

Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Propofol and excipients

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Qualitative composition of Propofol lipuro 2% excipients

Interventions

Propofol

Propofol and excipients

Intervention Type: DRUG

Placebo

Qualitative composition of Propofol lipuro 2% excipients

Intervention Type: DRUG

Other Intervention Names

Propofol lipuro 2%; Intralipid

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondation Ophtalmique Adolphe de Rothschild

Paris, , France

Countries

France

Other Identifiers

ILC_2016_5

Identifier Type: -

Identifier Source: org_study_id