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The purpose of this study is to evaluate if prediction of general anaesthesia level by the SmartpilotĀ® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartpilot View group | Experimental | General anaesthesia managed by the SmartpilotĀ® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the SmartpilotĀ® View software for the entire duration of general anaesthesia. |
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| Control group | Active Comparator | General anaesthesia without using the SmartpilotĀ® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthesia managed by the SmartpilotĀ® View | Device | General anaesthesia managed by the SmartpilotĀ® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the SmartpilotĀ® View software for the entire duration of general anaesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent in the "appropriate anaesthesia zone" | The "appropriate anaesthesia zone" is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg | participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Dose of propofol | participants will be followed for the duration anesthesia, an expected average of 5 hours | |
| Dose of sufentanil | participants will be followed for the duration anesthesia, an expected average of 5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathieu CONTE, M.D. | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Angers | Angers | 49933 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29028921 | Result | Leblanc D, Conte M, Masson G, Richard F, Jeanneteau A, Bouhours G, Chretien JM, Rony L, Rineau E, Lasocki S. SmartPilot(R) view-guided anaesthesia improves postoperative outcomes in hip fracture surgery: a randomized blinded controlled study. Br J Anaesth. 2017 Nov 1;119(5):1022-1029. doi: 10.1093/bja/aex317. |
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| General anesthesia managed without the SmartpilotĀ® View | Device | General anaesthesia without using the SmartpilotĀ® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room. |
|
| Time to extubation | end of anaesthesia |
| "NASA Task Load Index" | participants will be followed for the duration anesthesia, an expected average of 5 hours |
| Morphine consumption | participants will be followed for the duration in recovery room, an expected average of 24 hours |
| Incidence of awareness with recall during anaesthesia | postoperative day 1 |
| "Postoperative Quality Recovery Scale" | during recovery room (an expected average of 24 hours) and postoperative days 1 and 3 |
| Length of stay | postoperative day 30 |
| Mortality | postoperative day 30 |