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Dexmedetomidine on Segmental EEG Power Spectra

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ClinicalTrials.gov Identifier: NCT03515876
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Zhiyi Zuo, Sun Yat-sen University

Brief Summary:
To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status.

Condition or disease
Anesthesia EEG Power Spectra

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effects of Dexmedetomidine on Segmental EEG Power Spectra Activity Under Propofol-based Anesthesia
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. EEG power spectra [ Time Frame: From prior to anesthesia to 10 min after anesthesia. ]
    EEG power spectra monitored no-invasively by Narcotrend


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: From prior to anesthesia to 10 min after anesthesia. ]
    Blood pressure monitored no-invasively

  2. Respiration [ Time Frame: From prior to anesthesia to 10 min after anesthesia. ]
    Monitored no-invasively

  3. Heart rates [ Time Frame: From prior to anesthesia to 10 min after anesthesia. ]
    Monitored no-invasively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients undergoing hysteroscopic examination and surgery.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients for hysteroscopic examination and surgery under general anesthesia.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515876


Contacts
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Contact: Zhi Wang, MD 13622740039 wwzz1898@163.com

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Wang Zhi, MD, Ph.D.    13622740039    wwzz1898@163.com   
Principal Investigator: Zhi Wang         
Sponsors and Collaborators
Zhiyi Zuo
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Responsible Party: Zhiyi Zuo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03515876    
Other Study ID Numbers: 2018-52
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No