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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019979-29 | EudraCT Number |
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The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine |
|
| Placebo | Placebo Comparator | patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | bolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia. start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine |
| Measure | Description | Time Frame |
|---|---|---|
| administered dose of propofol during maintenance of anesthesia | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| administered dose of propofol during induction of anesthesia | day 1 | |
| administered doses of remifentanil during induction and maintenance of anesthesia | day 1 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hôpital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Tenon | Paris | 75020 | France |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | NaCl 9/00 (same volume as in the lidocaine group) start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00 |
|
| delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia |
| day 1 |
| hemodynamic abnormalities requiring treatment | day 1 |
| % of time with a BIS index between 40 and 60 | day 1 |
| postoperative morphine requirement | day 1 |
| incidence of postoperative nausea and vomiting | day 1 |
| % of patients with an explicit memorisation of the intraoperative period | second postoperative day |
| Aniline Compounds |
| D000588 | Amines |