Predicted Level of General Anaesthesia in Hip Fracture Surgery

University Hospital, Angers100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

100

Conditions

Hip Fracture Surgery

Interventions

General anesthesia managed by the Smartpilot® ViewDEVICE

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 anesthesia managed without the Smartpilot® ViewDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Angers

Angers, France

Outcomes

Primary Outcomes

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

Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery

Secondary Outcomes

Dose of propofol

Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours

Dose of sufentanil

Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours

Time to extubation

Time frame: end of anaesthesia

"NASA Task Load Index"

Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours

Morphine consumption

Time frame: participants will be followed for the duration in recovery room, an expected average of 24 hours

Incidence of awareness with recall during anaesthesia

Time frame: postoperative day 1

"Postoperative Quality Recovery Scale"

Time frame: during recovery room (an expected average of 24 hours) and postoperative days 1 and 3

Length of stay

Time frame: postoperative day 30

Data from ClinicalTrials.gov

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