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

Phase 4

Completed

• Conditions: Sedation
• Interventions: Drug: Placebo; Drug: Propofol

• Registration Number: NCT02771912
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Study Start: 2016-07
• Primary Completion: 2017-02-21
• Study Completion: 2017-02-21
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralipid	Placebo	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.
Propofol	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.

Primary Outcome Measures

Name	Time	Method
Number of self administered bolus	One day

Trial Locations

Locations (1)

Fondation Ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France