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CompletedNCT02035930Updated Jan 14, 2014

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

A Phase 4 interventional study of dexmedetomidine in Abnormal Menstrual Cycle, sponsored by Fudan University. Completed. Open to female participants aged 24 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-01-14.

Sponsored by Fudan University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
24 Years to 40 Years
Sex
Female
01

Study 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 .

02

Conditions studied

  • Abnormal Menstrual Cycle

Keywords

  • Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • a regular menstrual cycle
  • elective gynecologic surgery

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Other
    menstrual cycle,dexmedetomidine

    Drug: dexmedetomidine

Interventions

  • Drugdexmedetomidine
06

What researchers measure

Primary outcomes

  1. bispectral index at loss of eyelash reflex

    Time frame: up to 2 years

Secondary outcomes

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

    Time frame: up to 2 years

Other outcomes

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

    Time frame: up to 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02035930
Lead sponsor
Fudan University
Responsible party
Geng guiqi (professor, Fudan University) — Principal investigator
First posted
Jan 14, 2014
Start date
Nov 2010
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Jan 14, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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