Epileptiform EEG Patterns During Induction of General Anaesthesia With Sevoflurane Compared to Those With Propofol

NCT03209323 | Completed DMC

• 1 other identifier: SilesianMUKOAIIT6
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to assess the influence of volatile induction of general anaesthesia with sevoflurane using two different techniques and intravenous anaesthesia with propofol on the possible presence of epileptiform electroencephalograph patterns during the induction of general anaesthesia. We aimed to verify whether presence of epileptiform patterns (EPs) defined as polispikes (PS), rhytmic polispikes (RPS), periodic epileptiform discharges (PED) on Electroencephalographs (EEGs) influence the behaviour of values of the Bispectral Index (BIS), State (SE) and Response (RE), A-line Auto Regressive Index (AAI) derived from middle latency auditory evoked potentials (MLAEP) during the induction of general anaesthesia using abovementioned techniques and such variations may be useful in detection of presence of EPs.

Conditions

General Anaesthesia; Depth of Anaesthesia; Intraoperative Awareness; Seizures; Electroencephalography

Keywords

Epileptiform patterns; sevoflurane; propofol; bispectral index; state entropy; response entropy; A-line Auto Regressive Index; middle latency auditory evoked potentials

Outcome Measures

Primary Outcomes (1)

• presence of epileptiform patterns in patients EEGs

  the main objective is to measure the influence of volatile induction of general anaesthesia with sevoflurane using two different techniques and intravenous anaesthesia with propofol on the presence of epileptiform electroencephalograph patterns during the induction of general anaesthesia.

  intraoperative

Secondary Outcomes (3)

• observance of BIS score behaviour during presence of epileptiform patterns in patients EEGs

  intraoperative

• observance of values of state and response entropy behaviour during presence of epileptiform patterns in patients

  intraoperative

• observance of values of middle latency auditory evoked potentials behaviour during presence of epileptiform patterns in patients

  intraoperative

Study Arms (3)

sevoflurane - increasing concentrations

EXPERIMENTAL

The patient was breathing spontaneously via the face mask and the sevoflurane concentration in the inhaled gas was doubled every 10 breaths starting from 0.3 vol. % in a sequence 0.3-0.6-1.2-2.4-4.8-8 vol. % until a minimal alveolar concentration (MAC) of 2 was obtained in the exhalation gas. Electroencephalography (EEG), bispectral index (BIS), response and state entropy (RE and SE), middle latency auditory evoked potentials (MLAEP) were monitored.

Device: electroencephalography (EEG); Device: bispectral index (BIS); Device: response and state entropy (RE and SE); Device: middle latency auditory evoked potentials (MLAEP)

sevoflurane - vital capacity

EXPERIMENTAL

The anaesthetic circuit was prefilled with 8% sevoflurane. The patients were asked to exhale to the residual volume. Then the patients were explained to perform a vital-capacity breath with a face mask applied tightly to their faces. Then the patients were encouraged to hold their breaths as long as possible. Thereafter, the patients were asked to breathe spontaneously. Electroencephalography (EEG), bispectral index (BIS), response and state entropy (RE and SE), middle latency auditory evoked potentials (MLAEP) were monitored.

Device: electroencephalography (EEG); Device: bispectral index (BIS); Device: response and state entropy (RE and SE); Device: middle latency auditory evoked potentials (MLAEP)

propofol - intravenous induction

EXPERIMENTAL

the patients were preoxygenated with 100% oxygen following which propofol was intravenously administered at a single dose of 2.5 mg/kg of body weight, after which it was infused with an infusion speed of 4 mg/kg body weight/h. Electroencephalography (EEG), bispectral index (BIS), response and state entropy (RE and SE), middle latency auditory evoked potentials (MLAEP) were monitored.

Device: electroencephalography (EEG); Device: bispectral index (BIS); Device: response and state entropy (RE and SE)

Interventions

electroencephalography (EEG) DEVICE

Four EEG channels were recorded using electrode positions as defined in the International 10-20 System with Ag/AgCl2 cup electrodes (Spes Medica) attached to the scalp with EC2 Electrode Cream (Grass Technologies). The impedance was set below 1 k, and the electrodes were attached to module S/5 E-EEG of the anaesthetic monitor S/5 (GE Healthcare).

propofol - intravenous induction; sevoflurane - increasing concentrations; sevoflurane - vital capacity

bispectral index (BIS) DEVICE

The BIS score was derived from a sensor (Aspect Medical Systems) positioned diagonally on the patients' foreheads according to producer's instructions.

propofol - intravenous induction; sevoflurane - increasing concentrations; sevoflurane - vital capacity

response and state entropy (RE and SE) DEVICE

The respone and state entropy (RE and SE) score was derived from a sensor (Aspect Medical Systems) positioned diagonally on the patients' foreheads according to producer's instructions.

propofol - intravenous induction; sevoflurane - increasing concentrations; sevoflurane - vital capacity

middle latency auditory evoked potentials (MLAEP) DEVICE

value of A-line Auto Regressive Index (AAI) derived from middle latency auditory evoked potentials (MLAEP) (A-line Monitor, Danmeter A/S, Odense, Denmark) was observed which measures the central nervous system responsiveness to a specific auditory stimulus

sevoflurane - increasing concentrations; sevoflurane - vital capacity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• an American Society of Anaesthesiologists (ASA) score I-II
• written informed consent to undergo general anaesthesia

You may not qualify if:

• \- history of epilepsy, medical treatment that might interfere with the EEG (e.g., tranquilizers, antiepileptic drugs), pregnancy, drug or alcohol abuse, history of neurological disease or a neurosurgical operation that would impair EEG or BIS monitoring, history of pulmonary disease, or the presence of signs predicting difficult mask ventilation or intubation. any pre-existing epileptic EEG patterns in standard 30-minute initial EEG recordings performed in all the patients participating in the study.

Sponsors & Collaborators

• Medical University of Silesia: lead
• Silesian University of Medicine: collaborator

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (19)

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  PMID: 15155337 RESULT

• Sarkela MO, Ermes MJ, van Gils MJ, Yli-Hankala AM, Jantti VH, Vakkuri AP. Quantification of epileptiform electroencephalographic activity during sevoflurane mask induction. Anesthesiology. 2007 Dec;107(6):928-38. doi: 10.1097/01.anes.0000291444.68894.ee.

  PMID: 18043061 RESULT

• Gibert S, Sabourdin N, Louvet N, Moutard ML, Piat V, Guye ML, Rigouzzo A, Constant I. Epileptogenic effect of sevoflurane: determination of the minimal alveolar concentration of sevoflurane associated with major epileptoid signs in children. Anesthesiology. 2012 Dec;117(6):1253-61. doi: 10.1097/ALN.0b013e318273e272.

  PMID: 23103557 RESULT

• Kreuzer I, Osthaus WA, Schultz A, Schultz B. Influence of the sevoflurane concentration on the occurrence of epileptiform EEG patterns. PLoS One. 2014 Feb 26;9(2):e89191. doi: 10.1371/journal.pone.0089191. eCollection 2014.

  PMID: 24586585 RESULT

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  PMID: 10903015 RESULT

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  PMID: 17264717 RESULT

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  PMID: 25006849 RESULT

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  PMID: 11472278 RESULT

• Yli-Hankala A, Vakkuri A, Sarkela M, Lindgren L, Korttila K, Jantti V. Epileptiform electroencephalogram during mask induction of anesthesia with sevoflurane. Anesthesiology. 1999 Dec;91(6):1596-603. doi: 10.1097/00000542-199912000-00009.

  PMID: 10598599 RESULT

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  PMID: 8952311 RESULT

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  PMID: 1389813 RESULT

• Gajraj RJ, Doi M, Mantzaridis H, Kenny GN. Comparison of bispectral EEG analysis and auditory evoked potentials for monitoring depth of anaesthesia during propofol anaesthesia. Br J Anaesth. 1999 May;82(5):672-8. doi: 10.1093/bja/82.5.672.

  PMID: 10536541 RESULT

• Schraag S, Bothner U, Gajraj R, Kenny GN, Georgieff M. The performance of electroencephalogram bispectral index and auditory evoked potential index to predict loss of consciousness during propofol infusion. Anesth Analg. 1999 Nov;89(5):1311-5.

  PMID: 10553858 RESULT

• Pilge S, Kreuzer M, Karatchiviev V, Kochs EF, Malcharek M, Schneider G. Differences between state entropy and bispectral index during analysis of identical electroencephalogram signals: a comparison with two randomised anaesthetic techniques. Eur J Anaesthesiol. 2015 May;32(5):354-65. doi: 10.1097/EJA.0000000000000189.

  PMID: 25564779 RESULT

MeSH Terms

Conditions

Intraoperative Awareness; Seizures

Interventions

Electroencephalography; Consciousness Monitors

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Surgical Equipment; Equipment and Supplies

Study Officials

• Przemysław Jałowiecki

  Silesian University of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The EEGs recorded before and during the general anaesthesia induction analysed offline by a neurophysiologist with an expertise in anaesthetic EEGs, the recording technique, and the anaesthetic agent used unaware of group allocation of the participant.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: July 2, 2017
• First Posted: July 6, 2017
• Study Start: January 1, 2007
• Primary Completion: December 13, 2008
• Study Completion: December 13, 2008
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

PL (1)