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

NCT02771912 | Completed Phase 4

• 1 other identifier: ILC_2016_5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of self administered bolus

  One day

Study Arms (2)

Propofol

EXPERIMENTAL

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.

Drug: Propofol

Intralipid

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Propofol DRUG

Propofol and excipients

Also known as: Propofol lipuro 2%

Propofol

Placebo DRUG

Qualitative composition of Propofol lipuro 2% excipients

Also known as: Intralipid

Intralipid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should be operated of cataract under topical anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Interventions

Propofol; soybean oil, phospholipid emulsion

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 13, 2016
• Study Start: July 1, 2016
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

FR (1)