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Predicted Level of General Anaesthesia in Hip Fracture Surgery

Predicted Level of General Anaesthesia in Hip Fracture Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02556658
Acronym
NAPfem
Enrollment
100
Registered
2015-09-22
Start date
2015-02-28
Completion date
2016-04-30
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture Surgery

Keywords

Smartpilot View, Hip fracture surgery, Depth of anaesthesia, Intraoperative hypotension, Quality of anaesthesia

Brief summary

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.

Interventions

DEVICEGeneral anesthesia managed by the Smartpilot® View

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.

DEVICEGeneral anesthesia managed without the Smartpilot® View

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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of time spent in the appropriate anaesthesia zoneparticipants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgeryThe appropriate anaesthesia zone is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg

Secondary

MeasureTime frame
Dose of sufentanilparticipants will be followed for the duration anesthesia, an expected average of 5 hours
Time to extubationend of anaesthesia
NASA Task Load Indexparticipants will be followed for the duration anesthesia, an expected average of 5 hours
Morphine consumptionparticipants will be followed for the duration in recovery room, an expected average of 24 hours
Dose of propofolparticipants will be followed for the duration anesthesia, an expected average of 5 hours
Postoperative Quality Recovery Scaleduring recovery room (an expected average of 24 hours) and postoperative days 1 and 3
Length of staypostoperative day 30
Mortalitypostoperative day 30
Incidence of awareness with recall during anaesthesiapostoperative day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026