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Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram

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ClinicalTrials.gov Identifier: NCT01662622
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : August 14, 2012
Sponsor:
Collaborators:
Ministry of Health, China
National Natural Science Foundation of China
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

Tracking Information
First Submitted Date  ICMJE August 8, 2012
First Posted Date  ICMJE August 10, 2012
Last Update Posted Date August 14, 2012
Study Start Date  ICMJE March 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
MACie [ Time Frame: 30min ]
Minimal Alveolar Concentration of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01662622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
MACbs [ Time Frame: 30 min ]
Minimal Alveolar Concentration of sevoflurane inducing inducing burst suppression EEG (MACbs) in middle aged adults.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 9, 2012)
  • Hemodynamic parameters [ Time Frame: 3 min ]
    Hemodynamic parameters 2 min before and 3 min after skin incision
  • Use of phenylephrine [ Time Frame: 30 min ]
    Use of phenylephrine during induction and maintenance of anesthesia with sevoflurane.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
Official Title  ICMJE Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
Brief Summary Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.
Detailed Description Patients received sevoflurane for anesthesia induction and maintenance at preselected concentrations according to an 'up and down' design, with 0.2% as a stepsize. General anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated with cisatracurium. After a steady-state period of 30min without surgical stimulation, the state of isoelectric EEG was considered as significant when a burst suppression ratio of 100% last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor requirement to maintain cardiovascular system were also analysed according to the EEG state.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Middle Aged Patients
  • Sevoflurane
  • General Anesthesia
Intervention  ICMJE Drug: Sevoflurane
The design of experiment is referred to the "Dixon up-and-down" method. The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%. For each subject, 30 min interval time was given. The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached. Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision. Adrenergic reflexes positive cases were counted.
Study Arms  ICMJE Experimental: Sevoflurane
Anaesthesia was induced by 8% sevoflurane. Cisatracurium 0.15mg kg-1 was administered after loss of the lash reflex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow 2L min-1. Gas concentrations were analysed using a gas analyser.The end-tidal concentration of carbon dioxide was maintained at 4.7kPa; an esophageal temperature probe was inserted and a warming unit was used if necessary to maintain normothermia (35.5°-38.5°). The surgical incision was performed at least 30min after tracheal intubation. When arterial blood pressure (MAP) decrease exceeding 20% of baseline values. Phenylephrine 0.1mg was administered intravenously if necessary to maintained MAP and recorded.
Intervention: Drug: Sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2012)
31
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 45-65yr
  • upper abdominal surgery in general anaesthesia
  • ASA physical status classification of I or II

Exclusion Criteria:

  • neurological disease
  • received central nervous system-active drugs
  • cardiac ejection fraction less than 40%
  • history of difficult intubation or anticipated difficult intubation
  • daily alcohol consumption
  • obesity, defined as a body-mass index of more than 30
  • without informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01662622
Other Study ID Numbers  ICMJE TJMZK20120301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei Mei, Huazhong University of Science and Technology
Study Sponsor  ICMJE Huazhong University of Science and Technology
Collaborators  ICMJE
  • Ministry of Health, China
  • National Natural Science Foundation of China
Investigators  ICMJE
Study Chair: Yuke Tian, MD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
PRS Account Huazhong University of Science and Technology
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP