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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035930
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Geng guiqi, 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 .

Condition or disease Intervention/treatment Phase
Abnormal Menstrual Cycle Drug: dexmedetomidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
menstrual cycle,dexmedetomidine Drug: dexmedetomidine



Primary Outcome Measures :
  1. bispectral index at loss of eyelash reflex [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50 [ Time Frame: up to 2 years ]

Other Outcome Measures:
  1. duration from propofol administered to loss of eyelash reflex and bispectral index reduced to 50 [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Geng guiqi, professor, Fudan University
ClinicalTrials.gov Identifier: NCT02035930    
Other Study ID Numbers: TWang
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Geng guiqi, Fudan University:
Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action