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Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG

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ClinicalTrials.gov Identifier: NCT01705743
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

Brief Summary:
In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.

Condition or disease Intervention/treatment Phase
Middle Aged Patients General Anesthesia Drug: Sevoflurane+Nitrous oxide Drug: Sevoflurane Phase 4

Detailed Description:

Anaesthesia was induced by sevoflurane in oxygen. Cisatracurium 0.15 mg 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 of 2 L min-1. Anesthesia was maintained by sevoflurane or sevoflurane+60% nitrous oxide respectively. The surgical incision was performed at least 30 min after tracheal intubation, provided that the predetermined end-tidal sevoflurane concentration had been constant for at least 30 min and that the difference between inspired and end-tidal concentrations was less than 10%.

Brain electrical activity was measured using Narcotrend Monitor and S/5 Compact Anaesthesia Monitor, which displayed unprocessed EEG and burst suppression ratio, respectively. The design of the experiment is referred to the "Dixon up-and-down" method. To avid anaesthesia awareness, the first subject was designed to receive end-tidal sevoflurane concentration of 2.5 %. The presence or absence of isoelectric EEG (Entropy Module) of the preceding patient determined the end-tidal concentration of sevoflurane given to the next patient (with an increment size of 0.2%). The isoelectric EEG was considered as significant when the isoelectric state last for more than 1 min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimum Alveolar Concentration of Sevoflurane With 60% Nitrous Oxide Inducing Isoelectric EEG in Mid-aged Adults
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1 Sevoflurane+Nitrous oxide Drug: Sevoflurane+Nitrous oxide
60% nitrous oxide +40% oxygen+ Sevoflurane

Active Comparator: Group 2 Sevoflurane Drug: Sevoflurane
100% oxygen+ Sevoflurane




Primary Outcome Measures :
  1. MACie [ Time Frame: 30min ]
    Minimal Alveolar Concentration of sevoflurane and NO inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)



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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between 45 to 64 years old
  • ASA physical status class 1 or 2
  • elective abdominal surgery
  • Informed Consent

Exclusion Criteria:

  • history of 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
  • others judged inappropriate as subjects for the study by the Study Chair

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705743


Locations
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China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Chair: Yuke Tian, MD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

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Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01705743     History of Changes
Other Study ID Numbers: TJMZK20120903
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Keywords provided by Wei Mei, Huazhong University of Science and Technology:
anaesthesia
middle aged
minimal alveolar concentration
sevoflurane
nitrous oxide
isoelectric EEG
Additional relevant MeSH terms:
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Sevoflurane
Nitrous Oxide
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents