A Phase 4 interventional study of Sevoflurane+Nitrous oxide and Sevoflurane in Middle Aged Patients and General Anesthesia, sponsored by Huazhong University of Science and Technology. Completed at 1 site in China. Open to participants aged 45 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-02-04.
Sponsored by Huazhong University of Science and Technology · Phase 4, Interventional, and Treatment
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.
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.
Huazhong University of Science and Technology is the lead sponsor of 242 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Drug: Sevoflurane+Nitrous oxide
Drug: Sevoflurane
60% nitrous oxide +40% oxygen+ Sevoflurane
100% oxygen+ Sevoflurane
MACie
Minimal Alveolar Concentration of sevoflurane and NO inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
Time frame: 30min
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Huazhong University of Science and Technology