Effect of Sedatives on Regional Cerebral Oxygen Saturation (2)

February 14, 2019 updated by: Youn Yi Jo, Gachon University Gil Medical Center

Effect of Medazolam or Dexmedetomidine on Regional Cerebral Oxygen Saturation During Spinal Anesthesia in the Elderly Patients

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patinets who undergoing femur surgery under spinal anesthesia

Exclusion Criteria:

  • previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: midazolam
administration of midazolam during spinal anesthesia for target bispectral index 75-80
Drug: Midazolam
administration of midazolam during spinal anesthesia for target bispectral index 75-80
Other Names:
  • Mida
Active Comparator: dexmedetomidine
administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80
Drug: Dexmedetomidine
administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80
Other Names:
  • Dex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
regional cerebral oxygen saturation
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Study Director: Youn Yi Jo, MD, Gachon university Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCIRB2016-293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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