Effect of Sedatives on Regional Cerebral Oxygen Saturation

NCT ID: NCT02966743

Last Updated: 2019-02-15

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-10-31

Brief Summary

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

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Ischemia-Hypoxia

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

midazolam

administration of midazolam during spinal anesthesia for target bispectral index 75-80

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

administration of midazolam during spinal anesthesia for target bispectral index 75-80

dexmedetomidine

administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80

Interventions

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

Midazolam

administration of midazolam during spinal anesthesia for target bispectral index 75-80

Intervention Type DRUG

Dexmedetomidine

administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80

Intervention Type DRUG

Other Intervention Names

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

Mida Dex

Eligibility Criteria

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

Inclusion Criteria

* patinets who undergoing femur surgery under spinal anesthesia

Exclusion Criteria

* previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Youn Yi Jo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Youn Yi Jo, MD

Role: STUDY_DIRECTOR

Gachon University Gil Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GCIRB2016-293

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.