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

Phase 4CompletedNCT02035930

Fudan University110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

110

Conditions

Abnormal Menstrual Cycle

Interventions

dexmedetomidineDRUG

Eligibility

Sex: FEMALEMin age: 24 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

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

Data from ClinicalTrials.gov

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