Completed
NCT Number: NCT02035930
Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle
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 .
Completed
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Notify MeKey information
Conditions
Age range
24 year–40 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
bispectral index at loss of eyelash reflex
Time frame: up to 2 years
Secondary outcomes
-
propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50
Time frame: up to 2 years
Other outcomes
-
duration from propofol administered to loss of eyelash reflex and bispectral index reduced to 50
Time frame: up to 2 years
Sponsors and collaborators
Lead sponsor
Fudan University
Other
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jan 14, 2014
- Registry last updated
- Jan 14, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.