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This study compares automated administration of propofol and remifentanil versus manual administration during general anesthesia for a surgery. The closed-loop coadministration of propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.
Several monitors are currently proposed to evaluate the depth of hypnosis. The Conox monitor differentiates itself from the other brain monitor by calculating two EEG indexes, the qCon and the qNox. The qCon corresponds to the depth of the sedation and the qNox relates to the probability that a nociceptive stimulation triggers a movement of the patient. A controller allowing the automated titration of propofol guided by the qCon and remifentanil guided by the qNox has been developed. In preparation for a large multi-center control trial, this prospective randomized study evaluates the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one arm in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion (TCI) systems, and the second arm in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain qCon between 40 and 60, the recommended range during anesthesia by the manufacturer. It is expected the combined closed-loop anesthesia system group to do similar or better control to maintain the qCon in the desired range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full automation group | Experimental | Full automation control of propofol and remifentanil |
|
| Control group | Other | Manual control of of propofol and remifentanil using TCI system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed loop anesthesia | Device | Propofol and Remifentanil are administered automatically using a closed-loop system. The goal of this study is to compare manual titration versus automated titration of propofol and remifentanil in adult patients undergoing surgery guided by the electro-cortical activity. The aim in both group is to maintain the qCon in the range 40-60 during induction and maintenance of general anesthesia using the propofol in TCI mode. But also the qNox in the range 40-60 using remifentanil. The controller is based on a Proportional-Integral-derivative algorithm which steers a target to the pumps during induction and maintenance of general anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate sedation | Percentage of time with qCon index within the 40-60 range as recommended by the manufacturer of Conox monitor. Data from the Conox monitor (signal quality index, qCon index, qNox index, Suppression ratio) are recorded every second. | Start of general anesthesia maintenance, i.e. qCon below 60 for 30 consecutive seconds for the first time, until the end of propofol et remifentanil infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate analgesia | Percentage of time with qNox index within the 40-60 range as recommended by the manufacturer of Conox monitor. | Start of general anesthesia maintenance, i.e. qNox below 60 for 30 consecutive seconds for the first time, until the end of propofol et remifentanil infusion |
| Occurrence of Burst Suppression Ratio (bsr) |
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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 |
|---|---|---|---|---|---|---|
| Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon | Besançon | Bourgogne-Franche-Comté | 25030 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21233500 | Result | Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13. | |
| 24995461 |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Propofol | Drug | The dosage is modified automatically by the device or according to the new medical prescription. |
|
| Remifentanil | Drug | The dosage is modified automatically by the device or according to the new medical prescription. |
|
Presence of Burst Suppression defined by a rate > 10% for at least one minute |
| Intraoperative period |
| Dose of hypnotic drug | Total amount of propofol during the induction and the maintenance of the anesthesia | Intraoperative period |
| Dose of analgesic drug | Total amount of remifentanil during the induction and the maintenance of the anesthesia | Intraoperative period |
| Medical interventions on the dosage of drugs | Number of modifications of target of propofol and remifentanil | Intraoperative period |
| Hemodynamic status | Number of episodes of hemodynamic anomalies having required a treatment | Intraoperative period |
| Fluid therapy | Intraoperative volume loading and transfusion | Intraoperative period |
| Delay before awakening | Delay between the cessation of infusion of propofol and remifentanil and extubation | 12 hours |
| Explicit memorization | Awareness standardized questionnaire | 48 hours |
| Service d'Anesthésie du Centre Clinical |
| Soyaux |
| Poitou-Charentes |
| 16800 |
| France |
| Service d'Anesthésie, Hôpital Foch | Suresnes | Île-de-France Region | 92151 | France |
| Jensen EW, Valencia JF, Lopez A, Anglada T, Agusti M, Ramos Y, Serra R, Jospin M, Pineda P, Gambus P. Monitoring hypnotic effect and nociception with two EEG-derived indices, qCON and qNOX, during general anaesthesia. Acta Anaesthesiol Scand. 2014 Sep;58(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |