Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram

Phase 4

Completed

• Conditions: Middle Aged Patients; Sevoflurane; General Anesthesia
• Interventions: Drug: Sevoflurane

• Registration Number: NCT01662622
• Lead Sponsor: Huazhong University of Science and Technology

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-10
• Last Update Submitted: 2012-08-12
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sevoflurane	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.

Primary Outcome Measures

Name	Time	Method
MACie	30min	Minimal Alveolar Concentration of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)

Secondary Outcome Measures

Name	Time	Method
MACbs	30 min	Minimal Alveolar Concentration of sevoflurane inducing inducing burst suppression EEG (MACbs) in middle aged adults.

Trial Locations

Locations (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China