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CompletedNCT01705743Updated Feb 4, 2014

Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG

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

Phase
Phase 4
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Middle Aged Patients
  • General Anesthesia

Keywords

  • anaesthesia
  • middle aged
  • minimal alveolar concentration
  • sevoflurane
  • nitrous oxide
  • isoelectric EEG
03

In context

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 242 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    Group 1 Sevoflurane+Nitrous oxide

    Drug: Sevoflurane+Nitrous oxide

  • Active comparator
    Group 2 Sevoflurane

    Drug: Sevoflurane

Interventions

  • DrugSevoflurane+Nitrous oxide

    60% nitrous oxide +40% oxygen+ Sevoflurane

  • DrugSevoflurane

    100% oxygen+ Sevoflurane

06

What researchers measure

Primary outcomes

  1. MACie

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

    Time frame: 30min

07

Study locations

1 site
  • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01705743
Lead sponsor
Huazhong University of Science and Technology
Responsible party
Wei Mei (Associate Professor, Huazhong University of Science and Technology) — Principal investigator
First posted
Oct 12, 2012
Start date
Sep 2012
Primary completion
Sep 2013
Completion
Oct 2013
Last update
Feb 4, 2014

Study contacts

Yuke Tian, MD.
study chair · Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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