- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02360098
Emergence From Anesthesia in Anterior Temporal Lobectomy and Amygdalohippocampectomy Patients
July 10, 2020 updated by: Lashmi Venkatraghavan
Determinants of the Pattern of Emergence From Anesthesia in Patients Undergoing Anterior Temporal Lobectomy and Amygdalohippocampectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T2S8
- Toronto Western Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Emergence from anesthesia in anterior temporal lobectomy and amygdalohippocampectomy PATIENTS
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volumes of the Hippocampus, Thalamus and Amygdala
Time Frame: 1 day
|
Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lashmi Venkatraghavan, MD, Toronto Western Hospital/UHN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
February 2, 2015
First Submitted That Met QC Criteria
February 4, 2015
First Posted (Estimate)
February 10, 2015
Study Record Updates
Last Update Posted (Actual)
July 13, 2020
Last Update Submitted That Met QC Criteria
July 10, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 14-8212 BE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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