NCT02556658|CompletedPhase 4
Predicted Level of General Anaesthesia in Hip Fracture Surgery
NAPfem
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NAPfem
Sponsor study identifier
interventional
100
1 country
1
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 21, 2015
Actual (reported)February 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 22, 2015
Actual (reported)April 2016
Actual (reported)April 2016
Actual (reported)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
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
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
General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.
General anaesthesia without using the Smartpilot® 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.
General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.
General anaesthesia without using the Smartpilot® 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.
University Hospital Angers
Angers, 49933, France
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.
Mathieu CONTE, M.D.
University Hospital, Angers
100 participants (actual enrollment reported by the registry).
First Submitted
January 21, 2015
First Posted
September 22, 2015
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
AI-based Rehabilitation for Hip and Knee Surgery Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
November 17, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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