Predicted Level of General Anaesthesia in Hip Fracture Surgery

Hip Fracture Surgery Clinical Trial

— NAPfem  

Official title:

Predicted Level of General Anaesthesia in Hip Fracture Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556658
• Other study ID #: 2014-A01243-44
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture Surgery
• Hip Fractures

Intervention

Device:
• General 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.
• General 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.

Locations

Country	Name	City	State
France	University Hospital Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (1)

Leblanc D, Conté M, Masson G, Richard F, Jeanneteau A, Bouhours G, Chrétien JM, Rony L, Rineau E, Lasocki S. SmartPilot® view-guided anaesthesia improves postoperative outcomes in hip fracture surgery: a randomized blinded controlled study. Br J Anaesth. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery
Secondary	Dose of propofol		participants will be followed for the duration anesthesia, an expected average of 5 hours
Secondary	Dose of sufentanil		participants will be followed for the duration anesthesia, an expected average of 5 hours
Secondary	Time to extubation		end of anaesthesia
Secondary	"NASA Task Load Index"		participants will be followed for the duration anesthesia, an expected average of 5 hours
Secondary	Morphine consumption		participants will be followed for the duration in recovery room, an expected average of 24 hours
Secondary	Incidence of awareness with recall during anaesthesia		postoperative day 1
Secondary	"Postoperative Quality Recovery Scale"		during recovery room (an expected average of 24 hours) and postoperative days 1 and 3
Secondary	Length of stay		postoperative day 30
Secondary	Mortality		postoperative day 30