Postoperative Sedation After Cardiac Surgery

Study Results

Results pending

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.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Automated Postoperative Sedation After Cardiac Surgery

NCT03517735

Anesthesia Sedation Surgery, Cardiac

TERMINATED NA

Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery

NCT04039854

Coronary Heart Disease Cardiovascular Diseases

UNKNOWN PHASE4

Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients Cardiac Surgery

NCT05809518

Sedation Complication

COMPLETED NA

Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

NCT01151254

Cardiac Surgery

COMPLETED NA

Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

NCT00393003

Postoperative Sedation

COMPLETED PHASE4

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.

Surgery, Cardiac Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Automated postoperative sedation

Postoperative sedation is provided automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 40 and 60.

Group Type EXPERIMENTAL

Automated postoperative sedation

Intervention Type DEVICE

propofol

Intervention Type DRUG

remifentanil

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Automated postoperative sedation

Intervention Type DEVICE

propofol

Intervention Type DRUG

remifentanil

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

algorithm is the property of Medsteer SAS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* consent for participation
* cardiac surgical procedure requiring postoperative sedation

Exclusion Criteria

* pregnant women,
* neurological or muscular disorder
* high risk of revision surgery
* patients having required a redo operation if the postoperative period of sedation was less than 2 hours

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No