Clinical trial NCT02556658: Predicted Level of General Anaesthesia in Hip Fracture Surgery
Official title: Predicted Level of General Anaesthesia in Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fracture Surgery
Keywords: Smartpilot View
Hip fracture surgery
Depth of anaesthesia
Intraoperative hypotension
Quality of anaesthesia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Percentage of time spent in the "appropriate anaesthesia zone"
timeFrame: participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery
Secondary outcomes:
measure: Dose of propofol
timeFrame: participants will be followed for the duration anesthesia, an expected average of 5 hours
measure: Dose of sufentanil
timeFrame: participants will be followed for the duration anesthesia, an expected average of 5 hours
measure: Time to extubation
timeFrame: end of anaesthesia
measure: "NASA Task Load Index"
timeFrame: participants will be followed for the duration anesthesia, an expected average of 5 hours
measure: Morphine consumption
timeFrame: participants will be followed for the duration in recovery room, an expected average of 24 hours
measure: Incidence of awareness with recall during anaesthesia
timeFrame: postoperative day 1
measure: "Postoperative Quality Recovery Scale"
timeFrame: during recovery room (an expected average of 24 hours) and postoperative days 1 and 3
measure: Length of stay
timeFrame: postoperative day 30
measure: Mortality
timeFrame: postoperative day 30
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
Study officials:
affiliation: University Hospital, Angers
name: Mathieu CONTE, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.