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

Abnormal Menstrual Cycle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035930
• Other study ID #: TWang
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2014
• Last updated: January 11, 2014
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 40 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abnormal Menstrual Cycle
• Menstruation Disturbances

Intervention

Drug:
• dexmedetomidine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration from propofol administered to loss of eyelash reflex and bispectral index reduced to 50		up to 2 years	Yes
Primary	bispectral index at loss of eyelash reflex		up to 2 years	Yes
Secondary	propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50		up to 2 years	Yes