Effect of Dexmedetomidine on Bispectral Index and Propofo... | NCT02035930

Studies
Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle

NCT02035930

Sponsor

Fudan University

Status

Completed

Last Update Posted

Jan 14, 2014Estimated

Enrollment

110Actual

Phase

Phase 4

Conditions

Abnormal Menstrual Cycle

Interventions

dexmedetomidine

Countries

Not provided

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jan 10, 2014

First Submission Date that Met QC Criteria

Jan 11, 2014

First Posted Date

Jan 14, 2014Estimated

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

Jan 11, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The study was done to evaluate the effects of the follicular and luteal phases of the menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50 during propofol anesthesia, in patients with and without preoperative intravenous dexmedetomidine .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Label	Type	Description	Intervention Names
menstrual cycle,dexmedetomidine	Other		Drug: dexmedetomidine

Name	Type	Description	Arm Group Labels	Other Names
dexmedetomidine	Drug		menstrual cycle,dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bispectral index at loss of eyelash reflex		up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50		up to 2 years

Other Outcomes

Measure	Description	Time Frame
duration from propofol administered to loss of eyelash reflex and bispectral index reduced to 50		up to 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a regular menstrual cycle
elective gynecologic surgery

Exclusion Criteria:

pregnancy
breastfeeding
obesity
known hypersensitivity to drugs used in the study protocol;
use of psychotropic drugs and steroids within 72 hours before the surgery
central nervous system injury
renal impairment
alcoholism and opioid addiction.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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