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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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Smooth emergence (wake up) from anesthesia is an important consideration in patients undergoing neurosurgical procedures as blood pressure changes associated with violent emergence can cause intracranial hemorrhage and brain swelling. At the same time, emergence should also be quick so that patients' neurological function can be assessed at a timely manner. Pattern of emergence from anesthesia is poorly investigated and understood.
Epilepsy surgery involves resecting epileptogenic tissues including limbic structures which may be functionally normal. Hence the emergence process can be complicated in patients having diseased limbic structures or those having therapeutic removal of limbic structures as in epilepsy surgery. Limbic structures are responsible for memory, language and executive function and hence loss of some of these higher functions is to be expected in the postoperative period. Preoperative neuropsychological assessments are often used to predict their risk for postoperative loss of higher functions and behavior changes. In our experience the investigators have seen that there is a spectrum of emergence characteristics in patients undergoing temporal lobectomy that can vary from dangerously agitated patient to much sedated, unarousable patient. Delirium and agitation can be dangerous and have serious consequences for the patient such as injury, increased pain, hemorrhage, self-extubation and removal of catheters requiring physical or chemical restraint. On the other hand the unarousable patient may pose dangerous airway complications and limit neurological assessment in the immediate postoperative period. Hence it is essential to have a clue about post anesthesia emergence behavior in patients having epilepsy surgeries. The aim of this study is to look at the pattern of emergence from anesthesia after epilepsy surgery and to determine if preoperative neuropsychological assessment help predict the pattern of emergence in patients undergoing anterior temporal lobectomy and amygdalohippocampectomy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergence from Anesthesia | Other | There are no study related interventions in this study and perioperative care of these patients will be as per our standard practice The only study related protocol would be collecting the data on the emergence from anesthesia. The data will be collected from the time of turning off the anesthetic agents till the discharge from recovery room. Data collected include, vital signs, Glasgow coma scale( GCS), and Riker agitation- sedation score.. The patients will be assessed every 5 minutes for the first 30 minutes and every 10 minutes for the next 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Volumes of the Hippocampus, Thalamus and Amygdala | Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Emergence from anesthesia in anterior temporal lobectomy and amygdalohippocampectomy PATIENTS
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| Name | Affiliation | Role |
|---|---|---|
| Lashmi Venkatraghavan, MD | Toronto Western Hospital/UHN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | M5T2S8 | Canada |
Intraoperatively, all patients will have standard monitoring consisting of electrocardiography (ECG), pulse oximetry, end-tidal carbon dioxide (ETCO2), invasive and non-invasive blood pressure, temperature, urine output, depth of anesthesia (Entropy) and end tidal anesthetic agent concentration.
all patients will be seen by the anesthesiologists in the pre-anesthesia consult clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Agitated Emergence and Smooth Emergence | Number of consented patients to participate in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Comparison between agitated emergence and smooth emergence groups Sex/Gender data were not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Agitated Emergence | Demographic variables of patients woke up agitated from anesthesia |
| BG001 | Smooth Emergence | Demographic variables of patients with smooth wake up from anesthesia |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volumes of the Hippocampus, Thalamus and Amygdala | Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups | Comparison of volumes of the hippocampus, thalamus and amygdala in both groups | Posted | Mean | Standard Deviation | mm3 | 1 day |
|
1 day
Any adverse events detected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Agitated Emergence and Smooth Emergence | Demographic variables and anesthetic agent use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emad Al Azazi | TORONTO WESTERN HOSPITAL/UHN | 416-603-5800 | 6237 | emad.alazazi@uhnresearch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2014 | Jun 8, 2020 | Prot_SAP_000.pdf |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Sex/Gender data were not collected. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kg |
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| Height | Mean | Standard Deviation | cm |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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