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

January 11, 2014 updated by: Geng guiqi, Fudan University
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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: menstrual cycle,dexmedetomidine
Drug: dexmedetomidine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 11, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 11, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWang

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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