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Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG

Minimum Alveolar Concentration of Sevoflurane With 60% Nitrous Oxide Inducing Isoelectric EEG in Mid-aged Adults

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01705743
Enrollment
76
Registered
2012-10-12
Start date
2012-09-30
Completion date
2013-10-31
Last updated
2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Middle Aged Patients

Keywords

anaesthesia, middle aged, minimal alveolar concentration, sevoflurane, nitrous oxide, isoelectric EEG

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.

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.

Interventions

DRUGSevoflurane+Nitrous oxide

60% nitrous oxide +40% oxygen+ Sevoflurane

DRUGSevoflurane

100% oxygen+ Sevoflurane

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MACie30minMinimal Alveolar Concentration of sevoflurane and NO inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026