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

Phase 4

Completed

• Conditions: Abnormal Menstrual Cycle
• Interventions: Drug: dexmedetomidine

• Registration Number: NCT02035930
• Lead Sponsor: Fudan University

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-11
• Last Update Submitted: 2014-01-11
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
menstrual cycle,dexmedetomidine	dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
bispectral index at loss of eyelash reflex	up to 2 years

Secondary Outcome Measures

Name	Time	Method
propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50	up to 2 years