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Emergence From Anesthesia in Anterior Temporal Lobectomy and Amygdalohippocampectomy Patients

Determinants of the Pattern of Emergence From Anesthesia in Patients Undergoing Anterior Temporal Lobectomy and Amygdalohippocampectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02360098
Enrollment
36
Registered
2015-02-10
Start date
2014-12-31
Completion date
2017-03-31
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence From Anesthesia

Keywords

Emergence from Anesthesia, Anterior temporal lobectomy, Amygdalohippocampectomy, Anesthesia

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

University Health Network, Toronto
CollaboratorOTHER
Lashmi Venkatraghavan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients above the age of 18 who are scheduled for elective anterior temporal lobectomy and amygdalohippocampectomy under General Anesthesia

Exclusion criteria

* Lack of informed consent Patients needing intensive care unit postoperatively

Design outcomes

Primary

MeasureTime frameDescription
Volumes of the Hippocampus, Thalamus and Amygdala1 dayComparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups

Countries

Canada

Participant flow

Recruitment details

all patients will be seen by the anesthesiologists in the pre-anesthesia consult clinic.

Pre-assignment details

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.

Participants by arm

ArmCount
Agitated Emergence
Demographic variables of patients woke up agitated from anesthesia
9
Smooth Emergence
Demographic variables of patients with smooth wake up from anesthesia
20
Total29

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision7

Baseline characteristics

CharacteristicAgitated EmergenceSmooth EmergenceTotal
Age, Customized
Age
33 years
STANDARD_DEVIATION 11
36 years
STANDARD_DEVIATION 13
34.5 years
STANDARD_DEVIATION 12
Height174 cm
STANDARD_DEVIATION 10
170 cm
STANDARD_DEVIATION 9
172 cm
STANDARD_DEVIATION 8
Race and Ethnicity Not Collected0 Participants
Sex/Gender, Customized
Sex/Gender data were not collected.
0 Participants0 Participants0 Participants
Weight76 Kg
STANDARD_DEVIATION 15
75 Kg
STANDARD_DEVIATION 19
75.5 Kg
STANDARD_DEVIATION 17

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 29
other
Total, other adverse events
0 / 29
serious
Total, serious adverse events
0 / 29

Outcome results

Primary

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

Population: Comparison of volumes of the hippocampus, thalamus and amygdala in both groups

ArmMeasureGroupValue (MEAN)Dispersion
Agitated EmergenceVolumes of the Hippocampus, Thalamus and Amygdalaipsilateral hippocampus3578 mm3Standard Deviation 344
Agitated EmergenceVolumes of the Hippocampus, Thalamus and Amygdalacontralateral hippocampus3479 mm3Standard Deviation 452
Agitated EmergenceVolumes of the Hippocampus, Thalamus and Amygdalaipsilateral thalamus7311 mm3Standard Deviation 663
Agitated EmergenceVolumes of the Hippocampus, Thalamus and Amygdalacontralatera thalamus l7608 mm3Standard Deviation 908
Agitated EmergenceVolumes of the Hippocampus, Thalamus and Amygdalaipsilateral amygdala1331 mm3Standard Deviation 272
Agitated EmergenceVolumes of the Hippocampus, Thalamus and Amygdalacontralateral amygdala1321 mm3Standard Deviation 223
Smooth EmergenceVolumes of the Hippocampus, Thalamus and Amygdalaipsilateral amygdala1295 mm3Standard Deviation 285
Smooth EmergenceVolumes of the Hippocampus, Thalamus and Amygdalaipsilateral hippocampus3903 mm3Standard Deviation 516
Smooth EmergenceVolumes of the Hippocampus, Thalamus and Amygdalacontralatera thalamus l7631 mm3Standard Deviation 799
Smooth EmergenceVolumes of the Hippocampus, Thalamus and Amygdalacontralateral hippocampus3525 mm3Standard Deviation 569
Smooth EmergenceVolumes of the Hippocampus, Thalamus and Amygdalacontralateral amygdala1260 mm3Standard Deviation 230
Smooth EmergenceVolumes of the Hippocampus, Thalamus and Amygdalaipsilateral thalamus7479 mm3Standard Deviation 856

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026