Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study.
NCT ID: NCT01694901
Last Updated: 2019-06-28
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
150 participants
OBSERVATIONAL
2013-11-12
2017-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
How Lidocaine Affects Outcomes In Orthopedic Surgery Patients
NCT01179100
Detection of Consciousness by EEG and Auditory Evoked Potentials
NCT01720615
Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia
NCT01020643
General Anesthetic Mode and Postoperative Complications
NCT03335579
Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming
NCT03476213
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SmartPilot® system
50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia using the SmartPilot® system
No interventions assigned to this group
Standard arm
50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia according to the standard operating procedures of the department, i.e. manually controlled clinical anesthesia and EEG-derived parameters of anesthetic depth
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male/female patients with intended ratio of 1:1
* patients aged greater than or equal to 60 years
* scheduled duration of surgery longer than or equal to 60 minutes
* elective surgery (general/abdominal surgery, traumatological/orthopedic surgery, gynecology, urology) in general anesthesia
Exclusion Criteria
* Unability of German language use
* Lacking willingness to save and hand out data within the study
* Participation in another study according to the German Medicinal Products Act within 30 days before participation in the Smart-Outcome study
* Accommodation in an institution due to an official or judicial order
* (Unclear) history of alcohol or substances disabuse
* Member of staff of the Charité
* Neurological or psychiatric disease
* American Society of Anaesthesiologists (ASA) classification greater than or equal to class IV
* Moribund patients
Due to the underlying PKPD models of the SmartPilot® system, patient with the following characteristics cannot be anesthetized using SmartPilot®:
* Height \< 150 or \> 200 cm, respectively
* Weight \< 40 or \> 140 kg, respectively
* Body Mass Index \> 30
* Age \< 18 or \> 90 years of age, respectively
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Claudia Spies
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Claudia Spies
Prof. Dr. C. Claudia
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Spies Claudia, MD, Prof.
Role: STUDY_DIRECTOR
Charite University, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Smart-Outcome
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.