Skip to main content
OpenTrials
Completed

NCT Number: NCT02556658

Predicted Level of General Anaesthesia in Hip Fracture Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Fracture Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Angers

Angers, 49933, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General anesthesia managed by the Smartpilot® View

Device

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® View

Device

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.

Primary outcomes

  1. Percentage of time spent in the "appropriate anaesthesia zone"

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

    The "appropriate anaesthesia zone" is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg

Secondary outcomes

  1. Dose of propofol

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

  2. Dose of sufentanil

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

  3. Time to extubation

    Time frame: end of anaesthesia

  4. "NASA Task Load Index"

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

  5. Morphine consumption

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

  6. Incidence of awareness with recall during anaesthesia

    Time frame: postoperative day 1

  7. "Postoperative Quality Recovery Scale"

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

  8. Length of stay

    Time frame: postoperative day 30

  9. Mortality

    Time frame: postoperative day 30

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: NAPfem

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2015
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.