Effect of Sedatives on Regional Cerebral Oxygen Saturation

Cerebral Ischemia-Hypoxia Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02966743
• Other study ID #: GCIRB2016-293
• Status: Withdrawn
• Phase: N/A
• Start date: November 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2019
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• patinets who undergoing femur surgery under spinal anesthesia

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia-Hypoxia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Drug:
• Midazolam
administration of midazolam during spinal anesthesia for target bispectral index 75-80
• Dexmedetomidine
administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regional cerebral oxygen saturation		1 day