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EEG Changes During Induction of Propofol Anesthesia (PropoStatus)
| Condition or disease |
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| Anesthesia, General Healthy Subjects |
PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol. EEG changes are investigated in different levels of anesthesia from awake state to deep anesthesia in which burst suppression pattern (BSP) is seen in the EEG. Furthermore, the relation of EEG changes and clinically evaluated depth of anesthesia is studied.
The study population is comprised of neurologically healthy individuals who come to the hospital for elective surgery requiring general anesthesia. The patients will not receive any pre-medication. They will give a written consent to participate to the study. During induction of anesthesia, the vital signs will be monitored using the standard protocol of the operating room. EEG will be recorded using a self-adhesive disposable forehead electrode and wireless measurement device. The EEG is observed during the recording from a laptop or tablet computer. The anesthesia is induced using propofol with a fixed infusion rate of 30 mg/kg/h. The patient is asked to squeeze the anesthetist's hand repeatedly every 10 s. The moment at which the patients does not respond to the command anymore is considered as the loss of consciousness. The infusion is continued until BSP is observed in the EEG. The infusion is then continued for 3 min after which the recording of EEG is stopped. The administration of anesthesia is then continued as required by the operation.
| Study Type : | Observational |
| Actual Enrollment : | 20 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Frontal EEG Changes Using Self-adhesive Disposable Forehead Electrode and Wireless Measurement Device During Induction of Propofol Anesthesia |
| Actual Study Start Date : | October 25, 2018 |
| Actual Primary Completion Date : | February 5, 2019 |
| Actual Study Completion Date : | February 5, 2019 |
- EEG slow-wave activity [ Time Frame: Induction of anesthesia (approx. 10-30 min) ]EEG slow-wave activity is defined by the low-frequency (<1 Hz) signal power. The study investigates the topographic distribution of the activity as well as the coupling of the activity between the electrodes. The relation of slow-wave activity and loss of consciousness will be investigated as well.
- EEG activity on other frequency bands [ Time Frame: Induction of anesthesia (approx. 10-30 min) ]In addition to slow wave activity, the study investigates the topographic distribution of the activities on other frequency bands (delta, theta, alpha, beta) as well as the coupling of these activities between the electrodes.The relation of these other activities and loss of consciousness will be investigated as well.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- ASA 1-2 (no neurological or cardiovascular diseases)
Exclusion Criteria
- BMI > 30
| Finland | |
| South Karelia Central Hospital | |
| Lappeenranta, Finland, 53130 | |
| Principal Investigator: | Jukka Kortelainen, MD, PhD | University of Oulu |
| Tracking Information | |||||
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| First Submitted Date | May 7, 2019 | ||||
| First Posted Date | May 9, 2019 | ||||
| Last Update Posted Date | May 9, 2019 | ||||
| Actual Study Start Date | October 25, 2018 | ||||
| Actual Primary Completion Date | February 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
EEG slow-wave activity [ Time Frame: Induction of anesthesia (approx. 10-30 min) ] EEG slow-wave activity is defined by the low-frequency (<1 Hz) signal power. The study investigates the topographic distribution of the activity as well as the coupling of the activity between the electrodes. The relation of slow-wave activity and loss of consciousness will be investigated as well.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
EEG activity on other frequency bands [ Time Frame: Induction of anesthesia (approx. 10-30 min) ] In addition to slow wave activity, the study investigates the topographic distribution of the activities on other frequency bands (delta, theta, alpha, beta) as well as the coupling of these activities between the electrodes.The relation of these other activities and loss of consciousness will be investigated as well.
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | EEG Changes During Induction of Propofol Anesthesia | ||||
| Official Title | Assessment of Frontal EEG Changes Using Self-adhesive Disposable Forehead Electrode and Wireless Measurement Device During Induction of Propofol Anesthesia | ||||
| Brief Summary | PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol. | ||||
| Detailed Description |
PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol. EEG changes are investigated in different levels of anesthesia from awake state to deep anesthesia in which burst suppression pattern (BSP) is seen in the EEG. Furthermore, the relation of EEG changes and clinically evaluated depth of anesthesia is studied. The study population is comprised of neurologically healthy individuals who come to the hospital for elective surgery requiring general anesthesia. The patients will not receive any pre-medication. They will give a written consent to participate to the study. During induction of anesthesia, the vital signs will be monitored using the standard protocol of the operating room. EEG will be recorded using a self-adhesive disposable forehead electrode and wireless measurement device. The EEG is observed during the recording from a laptop or tablet computer. The anesthesia is induced using propofol with a fixed infusion rate of 30 mg/kg/h. The patient is asked to squeeze the anesthetist's hand repeatedly every 10 s. The moment at which the patients does not respond to the command anymore is considered as the loss of consciousness. The infusion is continued until BSP is observed in the EEG. The infusion is then continued for 3 min after which the recording of EEG is stopped. The administration of anesthesia is then continued as required by the operation. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Neurologically healthy individuals coming to hospital for elective surgery with general anesthesia | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
20 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | February 5, 2019 | ||||
| Actual Primary Completion Date | February 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Finland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03943745 | ||||
| Other Study ID Numbers | 31/2018 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University of Oulu | ||||
| Study Sponsor | University of Oulu | ||||
| Collaborators |
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| Investigators |
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| PRS Account | University of Oulu | ||||
| Verification Date | May 2019 | ||||
