Predicted Level of General Anaesthesia in Hip Fracture Surgery
NCT ID: NCT02556658
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2015-02-28
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Smartpilot View group
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 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.
Control group
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years old
* ASA classification 1, 2 or 3
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Angers
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mathieu CONTE, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Angers
Angers, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-A01243-44
Identifier Type: -
Identifier Source: org_study_id