- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03515876
Dexmedetomidine on Segmental EEG Power Spectra
The Effects of Dexmedetomidine on Segmental EEG Power Spectra Activity Under Propofol-based Anesthesia
Study Overview
Status
Conditions
Detailed Description
Three groups of patients undergoing hysteroscopic examination and surgery will be studied: 1) control group, patients will receive propofol intravenous infusion to provide anesthesia; 2) dexmedetomidine 0.5 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia; and 3) dexmedetomidine 1 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia.
Each group will have 20 patients.
General conditions including blood pressure, respiration, and heart rates will be recorded.
EEG power spectra activity will be recorded no-invasively by a Narcotrend EEG monitor.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Recruiting
- Sun Yat-sen Memorial Hospital
-
Contact:
- Wang Zhi, MD, Ph.D.
- Phone Number: 13622740039
- Email: wwzz1898@163.com
-
Principal Investigator:
- Zhi Wang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anesthesiologists Physical status I to II grade.
- body mass index 18 to 25 kg/m2
- no vision or hearing impairment
- will receive general anesthesia
Exclusion Criteria:
- with psychological or mental diseases
- with neurological diseases
- treating with steroids or with alcohol dependence.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Control
Patients will receive intravenous propofol infusion.
|
Dexmedetomidine 0.5 microgram/kg group
Patients will receive dexmedetomidine 0.5 microgram/kg and then intravenous propofol infusion.
|
Dexmedetomidine 1 microgram/kg group
Patients will receive dexmedetomidine 1 microgram/kg and then intravenous propofol infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG power spectra
Time Frame: From prior to anesthesia to 10 min after anesthesia.
|
EEG power spectra monitored no-invasively by Narcotrend
|
From prior to anesthesia to 10 min after anesthesia.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: From prior to anesthesia to 10 min after anesthesia.
|
Blood pressure monitored no-invasively
|
From prior to anesthesia to 10 min after anesthesia.
|
Respiration
Time Frame: From prior to anesthesia to 10 min after anesthesia.
|
Monitored no-invasively
|
From prior to anesthesia to 10 min after anesthesia.
|
Heart rates
Time Frame: From prior to anesthesia to 10 min after anesthesia.
|
Monitored no-invasively
|
From prior to anesthesia to 10 min after anesthesia.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-52
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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