Dexmedetomidine on Segmental EEG Power Spectra

Sponsor

Zhiyi Zuo (Other)

Overall Status

Unknown status

CT.gov ID

NCT03515876

Collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Enrollment

Location

14.4

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Apr 19, 2018

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

EEG power spectra [From prior to anesthesia to 10 min after anesthesia.]
EEG power spectra monitored no-invasively by Narcotrend

Secondary Outcome Measures

Blood pressure [From prior to anesthesia to 10 min after anesthesia.]
Blood pressure monitored no-invasively
Respiration [From prior to anesthesia to 10 min after anesthesia.]
Monitored no-invasively
Heart rates [From prior to anesthesia to 10 min after anesthesia.]
Monitored no-invasively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

Zhiyi Zuo
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhiyi Zuo, Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03515876

Other Study ID Numbers:

2018-52

First Posted:

May 4, 2018

Last Update Posted:

Apr 9, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 9, 2019