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

Primary Purpose

Hip Fracture Surgery

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
General anesthesia managed by the Smartpilot® View
General anesthesia managed without the Smartpilot® View
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fracture Surgery focused on measuring Smartpilot View, Hip fracture surgery, Depth of anaesthesia, Intraoperative hypotension, Quality of anaesthesia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smartpilot View group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dose of propofol
Dose of sufentanil
Time to extubation
"NASA Task Load Index"
Morphine consumption
Incidence of awareness with recall during anaesthesia
"Postoperative Quality Recovery Scale"
Length of stay
Mortality

Full Information

First Posted
January 21, 2015
Last Updated
November 15, 2020
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02556658
Brief Title
Predicted Level of General Anaesthesia in Hip Fracture Surgery
Acronym
NAPfem
Official Title
Predicted Level of General Anaesthesia in Hip Fracture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture Surgery
Keywords
Smartpilot View, Hip fracture surgery, Depth of anaesthesia, Intraoperative hypotension, Quality of anaesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartpilot View group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
General anesthesia managed by the Smartpilot® View
Intervention 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.
Intervention Type
Device
Intervention Name(s)
General anesthesia managed without the Smartpilot® View
Intervention 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.
Primary Outcome Measure Information:
Title
Percentage of time spent in the "appropriate anaesthesia zone"
Description
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 Outcome Measure Information:
Title
Dose of propofol
Time Frame
participants will be followed for the duration anesthesia, an expected average of 5 hours
Title
Dose of sufentanil
Time Frame
participants will be followed for the duration anesthesia, an expected average of 5 hours
Title
Time to extubation
Time Frame
end of anaesthesia
Title
"NASA Task Load Index"
Time Frame
participants will be followed for the duration anesthesia, an expected average of 5 hours
Title
Morphine consumption
Time Frame
participants will be followed for the duration in recovery room, an expected average of 24 hours
Title
Incidence of awareness with recall during anaesthesia
Time Frame
postoperative day 1
Title
"Postoperative Quality Recovery Scale"
Time Frame
during recovery room (an expected average of 24 hours) and postoperative days 1 and 3
Title
Length of stay
Time Frame
postoperative day 30
Title
Mortality
Time Frame
postoperative day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu CONTE, M.D.
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29028921
Citation
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.
Results Reference
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Predicted Level of General Anaesthesia in Hip Fracture Surgery

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