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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02035930
Enrollment
110
Registered
2014-01-14
Start date
2010-11-30
Completion date
2012-11-30
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Menstrual Cycle

Keywords

Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine

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 .

Interventions

DRUGdexmedetomidine

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
24 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
bispectral index at loss of eyelash reflexup to 2 years

Secondary

MeasureTime frame
propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50up to 2 years

Other

MeasureTime frame
duration from propofol administered to loss of eyelash reflex and bispectral index reduced to 50up to 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026