NCT02035930

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 .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

January 10, 2014

Last Update Submit

January 11, 2014

Conditions

Abnormal Menstrual Cycle

Keywords

Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • bispectral index at loss of eyelash reflex

    up to 2 years

Secondary Outcomes (1)

  • propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50

    up to 2 years

Other Outcomes (1)

  • duration from propofol administered to loss of eyelash reflex and bispectral index reduced to 50

    up to 2 years

Study Arms (1)

menstrual cycle,dexmedetomidine

OTHER
Drug: dexmedetomidine

Interventions

dexmedetomidineDRUG
menstrual cycle,dexmedetomidine

Eligibility Criteria

Age24 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • a regular menstrual cycle
  • elective gynecologic surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 14, 2014

Record last verified: 2014-01