Comparison of Different Propofol Formulations With or Without Remifentanil (PropofolRemi)

Hopital Foch

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Propofol (B-Braun) and remifentanil; Drug: propofol 1% (Astra-Zeneca) and remifentanil; Drug: Propofol (Astra-Zeneca), NaCl 0.9%; Drug: Propofol (Astra-Zeneca) and remifentanil; Drug: Propofol (B-Braun) and NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT01592162

2011-002644-27 (Other Identifier)

2011/34

Details and patient eligibility

About

The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.

Enrollment: 409 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for an intravenous induction of anesthesia with propofol

Exclusion criteria

• Age under 18
• Pregnancy or breastfeeding
• Allergy to propofol, soya or peanuts,
• Allergy to remifentanil,
• History of central neurological disorder or brain injury,
• Patients receiving psychotropic drugs,
• Patient with a pacemaker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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409 participants in 9 patient groups

propofol 1% (Astra-Zeneca) - remi 0

Active Comparator group

Description:

propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml

Treatment:

Drug: Propofol (Astra-Zeneca), NaCl 0.9%

Drug: Propofol (Astra-Zeneca), NaCl 0.9%

propofol 1% (Astra-Zeneca) - remi 2

Active Comparator group

Description:

propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml

Treatment:

Drug: propofol 1% (Astra-Zeneca) and remifentanil

Drug: propofol 1% (Astra-Zeneca) and remifentanil

propofol 1% (Astra-Zeneca) - remi 4

Active Comparator group

Description:

propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml

Treatment:

Drug: propofol 1% (Astra-Zeneca) and remifentanil

Drug: propofol 1% (Astra-Zeneca) and remifentanil

propofol 1% (Fresenius) - remi 0

Active Comparator group

Description:

propofol 1% (Fresenius) plus remifentanil 0 ng/ml

Treatment:

Drug: Propofol (Astra-Zeneca), NaCl 0.9%

Drug: Propofol (Astra-Zeneca), NaCl 0.9%

propofol 1% (Fresenius) - remi 2

Active Comparator group

Description:

propofol 1% (Fresenius) plus remifentanil 2 ng/ml

Treatment:

Drug: Propofol (Astra-Zeneca) and remifentanil

Drug: Propofol (Astra-Zeneca) and remifentanil

propofol 1% (Fresenius) - remi 4

Active Comparator group

Description:

propofol 1% (Fresenius) plus remifentanil 4 ng/ml

Treatment:

Drug: Propofol (Astra-Zeneca) and remifentanil

Drug: Propofol (Astra-Zeneca) and remifentanil

propofol 1% (B-Braun) - remi 0

Active Comparator group

Description:

propofol 1% (B-Braun) plus remifentanil 0 ng/ml

Treatment:

Drug: Propofol (B-Braun) and NaCl 0.9%

propofol 1% (B-Braun) - remi 2

Active Comparator group

Description:

propofol 1% (B-Braun) plus remifentanil 2 ng/ml

Treatment:

Drug: Propofol (B-Braun) and remifentanil

Drug: Propofol (B-Braun) and remifentanil

propofol 1% (B-Braun) - remi 4

Active Comparator group

Description:

propofol 1% (B-Braun) plus remifentanil 4 ng/ml

Treatment:

Drug: Propofol (B-Braun) and remifentanil

Drug: Propofol (B-Braun) and remifentanil