Dexmedetomidine on Segmental EEG Power Spectra | NCT03515876

Studies
Dexmedetomidine on Segmental EEG Power Spectra

NCT03515876

Sponsor

Zhiyi Zuo

Status

Unknown status

Last Update Posted

Apr 9, 2019Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Anesthesia
EEG Power Spectra

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2018Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Apr 23, 2018

First Submission Date that Met QC Criteria

Apr 23, 2018

First Posted Date

May 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2019

Last Update Posted Date

Apr 9, 2019Actual

Name	Class
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EEG power spectra	EEG power spectra monitored no-invasively by Narcotrend	From prior to anesthesia to 10 min after anesthesia.

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	Blood pressure monitored no-invasively	From prior to anesthesia to 10 min after anesthesia.
Respiration	Monitored no-invasively

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Patients undergoing hysteroscopic examination and surgery.

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

patients for hysteroscopic examination and surgery under general anesthesia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhi Wang, MD	Contact	13622740039		wwzz1898@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-Sen Memorial Hospital	Recruiting	Guangzhou	Guangdong	510120	China