An observational study in Emergence From Anesthesia, sponsored by Lashmi Venkatraghavan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-13.
Sponsored by Lashmi Venkatraghavan · Observational
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.
Lashmi Venkatraghavan is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Emergence from anesthesia in anterior temporal lobectomy and amygdalohippocampectomy PATIENTS
Exclusion Criteria:
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.
Volumes of the Hippocampus, Thalamus and Amygdala
Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups
Time frame: 1 day
all patients will be seen by the anesthesiologists in the pre-anesthesia consult clinic.
| Milestone | Agitated Emergence and Smooth Emergence |
|---|---|
| Started | 36 |
| Completed | 29 |
| Not completed | 7 |
| Withdrew: Physician decision | 7 |
Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups
| mm3 | Agitated Emergence | Smooth Emergence |
|---|---|---|
| ipsilateral hippocampus | 3578 ± 344 | 3903 ± 516 |
| contralateral hippocampus | 3479 ± 452 | 3525 ± 569 |
| ipsilateral thalamus | 7311 ± 663 | 7479 ± 856 |
| contralatera thalamus l | 7608 ± 908 | 7631 ± 799 |
| ipsilateral amygdala | 1331 ± 272 | 1295 ± 285 |
| contralateral amygdala | 1321 ± 223 | 1260 ± 230 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Agitated Emergence and Smooth Emergence | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
Comparison between agitated emergence and smooth emergence groups Sex/Gender data were not collected.
| Age, Customized(years) | Agitated Emergence | Smooth Emergence | Total |
|---|---|---|---|
| Age | 33 ± 11 | 36 ± 13 | 34.5 ± 12 |
| Sex/Gender, Customized(Participants) | Agitated Emergence | Smooth Emergence | Total |
|---|---|---|---|
| Sex/Gender data were not collected. | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Agitated Emergence | Smooth Emergence | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Weight(Kg) | Agitated Emergence | Smooth Emergence | Total |
|---|---|---|---|
| Mean | 76 ± 15 | 75 ± 19 | 75.5 ± 17 |
| Height(cm) | Agitated Emergence | Smooth Emergence | Total |
|---|---|---|---|
| Mean | 174 ± 10 | 170 ± 9 | 172 ± 8 |
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Lashmi Venkatraghavan