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

Seizures Clinical Trial

— EEG  

Official title:

Influence of Volatile Induction of General Anaesthesia With Sevoflurane Using Two Different Techniques and Intravenous Induction Using Propofol on the Epileptiform Electroencephalograph Patterns:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209323
• Other study ID #: SilesianMUKOAIIT6
• Status: Completed
• Phase: N/A
• First received: July 2, 2017
• Last updated: July 7, 2017
• Start date: January 1, 2007
• Est. completion date: December 13, 2008

Study information

• Verified date: July 2017
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Both sevoflurane and propofol are considered safe and potent anaesthetics and are used for induction or coinduction of general anaesthesia. During all stages of general anaesthesia, both agents may induce seizure-like movements or seizures (clinically manifested events and confirming electroencephalographic pattern) accompanied by haemodynamic instability. Their proconvulsant activity should be verified and assessed.

The aim of the additional analysis was to identify whether observance of the variations of values displayed on different depth of anaesthesia monitors (DOA monitors) reliably reflect the actual depth of general anaesthesia during presence of epileptiform patterns (EPs) in EEGs during VIGA with sevoflurane using two different techniques and intravenous induction of general anaesthesia with single dose of propofol.

We performed standard 30-minute initial EEG recordings for all patients participating in the study to exclude any pre-existing epileptic EEG patterns. We took the initial EEG recordings in a dark quiet room for 5 minutes as a baseline, followed by three eye opening and closing sequences of 10 seconds each and photostimulation lasting 10 minutes (flash stimuli at frequencies of 3/6/9/12 Hz- alpha; 15/18/21/24 Hz- beta). Then we obtained another baseline reading and we asked the patients to achieve a state of hyperventilation by taking 20 forceful breathes per minute for five minutes. Finally, we obtained another baseline reading.

Throughout the induction of anaesthesia and the surgery, standard monitoring procedures were utilised to pay close attention to the vital parameters such as non-invasive arterial pressure (BP), heart rate (HR), standard electrocardiography (ECG) II, arterial oxygen saturation (SaO2), fraction of inspired oxygen in the gas mixture (FiO2), facial electromyography (fEMG), fraction of inspired sevoflurane (FiAA), fraction of expired sevoflurane (FeAA), exhaled carbon dioxide concentration (etCO2), minimal alveolar concentration of sevoflurane (MAC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 13, 2008
• Est. primary completion date: December 13, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• an American Society of Anaesthesiologists (ASA) score I-II

• written informed consent to undergo general anaesthesia

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• electroencephalography (EEG)
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).
• bispectral index (BIS)
The BIS score was derived from a sensor (Aspect Medical Systems) positioned diagonally on the patients' foreheads according to producer's instructions.
• response and state entropy (RE and SE)
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.
• middle latency auditory evoked potentials (MLAEP)
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

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Sosnowiec	Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Silesian University of Medicine

Country where clinical trial is conducted

Poland, 

References & Publications (19)

Aho AJ, Yli-Hankala A, Lyytikäinen LP, Jäntti V. Facial muscle activity, Response Entropy, and State Entropy indices during noxious stimuli in propofol-nitrous oxide or propofol-nitrous oxide-remifentanil anaesthesia without neuromuscular block. Br J Anae — View Citation

Ben-Menachem E, Zalcberg D. Depth of anesthesia monitoring: a survey of attitudes and usage patterns among Australian anesthesiologists. Anesth Analg. 2014 Nov;119(5):1180-5. doi: 10.1213/ANE.0000000000000344. — View Citation

Chinzei M, Sawamura S, Hayashida M, Kitamura T, Tamai H, Hanaoka K. Change in bispectral index during epileptiform electrical activity under sevoflurane anesthesia in a patient with epilepsy. Anesth Analg. 2004 Jun;98(6):1734-6, table of contents. — View Citation

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. — View Citation

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. Anesthesiolog — View Citation

Jääskeläinen SK, Kaisti K, Suni L, Hinkka S, Scheinin H. Sevoflurane is epileptogenic in healthy subjects at surgical levels of anesthesia. Neurology. 2003 Oct 28;61(8):1073-8. — View Citation

Jensen EW, Lindholm P, Henneberg SW. Autoregressive modeling with exogenous input of middle-latency auditory-evoked potentials to measure rapid changes in depth of anesthesia. Methods Inf Med. 1996 Sep;35(3):256-60. — View Citation

Julliac B, Guehl D, Chopin F, Arne P, Burbaud P, Sztark F, Cros AM. Risk factors for the occurrence of electroencephalogram abnormalities during induction of anesthesia with sevoflurane in nonepileptic patients. Anesthesiology. 2007 Feb;106(2):243-51. — View Citation

Kaisti KK, Jääskeläinen SK, Rinne JO, Metsähonkala L, Scheinin H. Epileptiform discharges during 2 MAC sevoflurane anesthesia in two healthy volunteers. Anesthesiology. 1999 Dec;91(6):1952-5. — View Citation

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. — View Citation

Newton DE, Thornton C, Konieczko KM, Jordan C, Webster NR, Luff NP, Frith CD, Doré CJ. Auditory evoked response and awareness: a study in volunteers at sub-MAC concentrations of isoflurane. Br J Anaesth. 1992 Aug;69(2):122-9. — View Citation

Pilge S, Jordan D, Kochs EF, Schneider G. Sevoflurane-induced epileptiform electroencephalographic activity and generalized tonic-clonic seizures in a volunteer study. Anesthesiology. 2013 Aug;119(2):447. doi: 10.1097/ALN.0b013e31827335b9. — View Citation

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 Anaest — View Citation

Särkelä MO, Ermes MJ, van Gils MJ, Yli-Hankala AM, Jäntti VH, Vakkuri AP. Quantification of epileptiform electroencephalographic activity during sevoflurane mask induction. Anesthesiology. 2007 Dec;107(6):928-38. — View Citation

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. — View Citation

Vakkuri A, Jantti V, Särkelä M, Lindgren L, Korttila K, Yli-Hankala A. Epileptiform EEG during sevoflurane mask induction: effect of delaying the onset of hyperventilation. Acta Anaesthesiol Scand. 2000 Jul;44(6):713-9. — View Citation

Vakkuri A, Yli-Hankala A, Särkelä M, Lindgren L, Mennander S, Korttila K, Saarnivaara L, Jäntti V. Sevoflurane mask induction of anaesthesia is associated with epileptiform EEG in children. Acta Anaesthesiol Scand. 2001 Aug;45(7):805-11. — View Citation

Viertiö-Oja H, Maja V, Särkelä M, Talja P, Tenkanen N, Tolvanen-Laakso H, Paloheimo M, Vakkuri A, Yli-Hankala A, Meriläinen P. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. Acta Anaesthesiol Scand. 2004 Feb;48(2):154-61. — View Citation

Yli-Hankala A, Vakkuri A, Särkelä M, Lindgren L, Korttila K, Jäntti V. Epileptiform electroencephalogram during mask induction of anesthesia with sevoflurane. Anesthesiology. 1999 Dec;91(6):1596-603. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	observance of BIS score behaviour during presence of epileptiform patterns in patients EEGs	the objective is to measure the BIS index variations during presence of EPs in patients' EEGs during volatile induction of general anaesthesia (VIGA) with sevoflurane using two different anaesthetic regimens compared to intravenous induction of general anaesthesia using single dose of propofol.	intraoperative
Secondary	observance of values of state and response entropy behaviour during presence of epileptiform patterns in patients	the objective is to measure values of state and response entropy index variations during presence of EPs in patients' EEGs during volatile induction of general anaesthesia (VIGA) with sevoflurane using two different anaesthetic regimens compared to intravenous induction of general anaesthesia using single dose of propofol.	intraoperative
Secondary	observance of values of middle latency auditory evoked potentials behaviour during presence of epileptiform patterns in patients	the objective is to measure values of middle latency auditory evoked potentials during presence of EPs in patients' EEGs during volatile induction of general anaesthesia (VIGA) with sevoflurane using two different anaesthetic regimens compared to intravenous induction of general anaesthesia using single dose of propofol.	intraoperative