General AnaesthesiaEEGNCT03209323
Epileptiform EEG Patterns During Induction of General Anaesthesia With Sevoflurane Compared to Those With Propofol
A study testing electroencephalography (EEG), bispectral index (BIS) and response and state entropy (RE and SE) in people with General Anaesthesia and Depth of Anaesthesia, run by Medical University of Silesia at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- General Anaesthesia, Depth of Anaesthesia, Intraoperative Awareness
- What is being tested?
- electroencephalography (EEG), bispectral index (BIS) and response and state entropy (RE and SE)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2007to 13 Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an American Society of Anaesthesiologists (ASA) score I-II
- written informed consent to undergo general anaesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Silesia
Sosnowiec, Silesian Voivodeship, 41-200
About this study
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:
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.
Read the detailed 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).
- Conditions
- General Anaesthesia, Depth of Anaesthesia, Intraoperative Awareness, Seizures, Electroencephalography
- Being tested
- electroencephalography (EEG), bispectral index (BIS), response and state entropy (RE and SE), middle latency auditory evoked potentials (MLAEP)
- Keywords
- Epileptiform patterns, sevoflurane, propofol, bispectral index, state entropy, response entropy, A-line Auto Regressive Index, middle latency auditory evoked potentials
- Medical subject headings
- Intraoperative Awareness, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: electroencephalography (EEG); Device: bispectral index (BIS); Device: response and state entropy (RE and SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
Secondary outcomes (3)
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.
Measured: intraoperative
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.
Measured: intraoperative
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.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Jan 2007
- Primary completion13 Dec 2008
- Study completion13 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for General AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Silesian University of Medicine
- Responsible party
- Principal investigator, Michał Stasiowski, Medical University of Silesia
- Investigators
- Przemysław Jałowiecki, Principal investigator, Silesian University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209323
- Sponsor's protocol ID
- SilesianMUKOAIIT6
- Acronym
- EEG
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: articles in Clinical Monitoring and Computing in 2017, case reports
Publications
Viertio-Oja H, Maja V, Sarkela M, Talja P, Tenkanen N, Tolvanen-Laakso H, Paloheimo M, Vakkuri A, Yli-Hankala A, Merilainen 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. doi: 10.1111/j.0001-5172.2004.00322.x. No abstract available.
PubMed 14995936Chinzei 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):1734-1736. doi: 10.1213/01.ANE.0000117282.72866.26.
PubMed 15155337Sarkela 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.
PubMed 18043061Gibert 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.
PubMed 23103557Kreuzer 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.
PubMed 24586585Jaaskelainen 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. doi: 10.1212/01.wnl.0000090565.15739.8d.
PubMed 14581667Pilge 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. No abstract available.
PubMed 23221897Kaisti KK, Jaaskelainen SK, Rinne JO, Metsahonkala L, Scheinin H. Epileptiform discharges during 2 MAC sevoflurane anesthesia in two healthy volunteers. Anesthesiology. 1999 Dec;91(6):1952-5. doi: 10.1097/00000542-199912000-00052. No abstract available.
PubMed 10598642Vakkuri A, Jantti V, Sarkela 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. doi: 10.1034/j.1399-6576.2000.440609.x.
PubMed 10903015Julliac 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. doi: 10.1097/00000542-200702000-00011.
PubMed 17264717Ben-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.
PubMed 25006849Vakkuri A, Yli-Hankala A, Sarkela M, Lindgren L, Mennander S, Korttila K, Saarnivaara L, Jantti V. Sevoflurane mask induction of anaesthesia is associated with epileptiform EEG in children. Acta Anaesthesiol Scand. 2001 Aug;45(7):805-11. doi: 10.1034/j.1399-6576.2001.045007805.x.
PubMed 11472278Yli-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.
PubMed 10598599Aho AJ, Yli-Hankala A, Lyytikainen LP, Jantti 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 Anaesth. 2009 Feb;102(2):227-33. doi: 10.1093/bja/aen356. Epub 2008 Dec 25.
PubMed 19112059Jensen 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.
PubMed 8952311
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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:
- ClinicalTrials.gov ID
- NCT03209323
- Acronym / sponsor ID
- EEG / SilesianMUKOAIIT6
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Silesian University of Medicine
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 13 Dec 2008 (actual)
- Study completion
- 13 Dec 2008 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sevoflurane - increasing concentrations | Experimental | Device: electroencephalography (EEG), Device: bispectral index (BIS), Device: response and state entropy (RE and SE), Device: middle latency auditory evoked potentials (MLAEP)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. |
| sevoflurane - vital capacity | Experimental | Device: electroencephalography (EEG), Device: bispectral index (BIS), Device: response and state entropy (RE and SE), Device: middle latency auditory evoked potentials (MLAEP)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. |
| propofol - intravenous induction | Experimental | Device: electroencephalography (EEG), Device: bispectral index (BIS), Device: response and state entropy (RE and SE)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. |
Who may qualify
- Ages
- 18 to 70 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- an American Society of Anaesthesiologists (ASA) score I-II
- written informed consent to undergo general anaesthesia
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | propofol - intravenous induction, sevoflurane - increasing concentrations, sevoflurane - vital capacity |
| 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. | Device | propofol - intravenous induction, sevoflurane - increasing concentrations, sevoflurane - vital capacity |
| 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. | Device | propofol - intravenous induction, sevoflurane - increasing concentrations, sevoflurane - vital capacity |
| 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 | Device | sevoflurane - increasing concentrations, sevoflurane - vital capacity |
Primary outcome
presence of epileptiform patterns in patients EEGs
Time frame: intraoperative
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.
3 secondary outcomes
observance of BIS score behaviour during presence of epileptiform patterns in patients EEGs
Time frame: intraoperative
observance of values of state and response entropy behaviour during presence of epileptiform patterns in patients
Time frame: intraoperative
observance of values of middle latency auditory evoked potentials behaviour during presence of epileptiform patterns in patients
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Background: PubMed 14995936Viertio-Oja H, Maja V, Sarkela M, Talja P, Tenkanen N, Tolvanen-Laakso H, Paloheimo M, Vakkuri A, Yli-Hankala A, Merilainen 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. doi: 10.1111/j.0001-5172.2004.00322.x. No abstract available.
- Results publication: PubMed 15155337Chinzei 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):1734-1736. doi: 10.1213/01.ANE.0000117282.72866.26.
- Results publication: PubMed 18043061Sarkela 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.
- Results publication: PubMed 23103557Gibert 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.
- Results publication: PubMed 24586585Kreuzer 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.
- Results publication: PubMed 14581667Jaaskelainen 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. doi: 10.1212/01.wnl.0000090565.15739.8d.
- Results publication: PubMed 23221897Pilge 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. No abstract available.
- Results publication: PubMed 10598642Kaisti KK, Jaaskelainen SK, Rinne JO, Metsahonkala L, Scheinin H. Epileptiform discharges during 2 MAC sevoflurane anesthesia in two healthy volunteers. Anesthesiology. 1999 Dec;91(6):1952-5. doi: 10.1097/00000542-199912000-00052. No abstract available.
- Results publication: PubMed 10903015Vakkuri A, Jantti V, Sarkela 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. doi: 10.1034/j.1399-6576.2000.440609.x.
- Results publication: PubMed 17264717Julliac 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. doi: 10.1097/00000542-200702000-00011.
- Results publication: PubMed 25006849Ben-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.
- Results publication: PubMed 11472278Vakkuri A, Yli-Hankala A, Sarkela M, Lindgren L, Mennander S, Korttila K, Saarnivaara L, Jantti V. Sevoflurane mask induction of anaesthesia is associated with epileptiform EEG in children. Acta Anaesthesiol Scand. 2001 Aug;45(7):805-11. doi: 10.1034/j.1399-6576.2001.045007805.x.
- Individual participant dataSharing planned: Undecided. articles in Clinical Monitoring and Computing in 2017, case reports
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Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Przemysław Jałowiecki principal investigator
Silesian University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography (EEG), bispectral index (BIS) and response and state entropy (RE and SE) in people with General Anaesthesia and Depth of Anaesthesia, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of epileptiform patterns in patients EEGs (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209323, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.