Predicted Level of General Anaesthesia in Hip Fracture Surgery (NAPfem)

University Hospital, Angers

Status and phase: Completed; Phase 4

Conditions: Hip Fracture Surgery

Treatments: Device: General anesthesia managed without the Smartpilot® View; Device: General anesthesia managed by the Smartpilot® View

Study type: Interventional

Funder types: Other

Identifiers

NCT02556658

2014-A01243-44

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing hip fracture surgery under general anaesthesia
• Age ≥ 18 years old
• ASA classification 1, 2 or 3

Exclusion criteria

• Patient not insured by a social security scheme
• Adult patient under tutorship or curatorship
• Age over 18 years old or under 90 years old
• Weight under 40 or over 140 kilos and/or height under 150 or over 200 cm
• Body mass index > 35
• Contraindication to one or more anaesthetics used in the study
• Pregnancy or breastfeeding
• Unweaned alcoholism
• ASA classification 4 or 5
• Patient undergoing hip fracture surgery under spinal anaesthesia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Smartpilot View group

Experimental group

Description:

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.

Treatment:

Device: General anesthesia managed by the Smartpilot® View

Control group

Active Comparator group

Description:

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.

Treatment:

Device: General anesthesia managed without the Smartpilot® View