Emergence From AnesthesiaNCT02360098
Emergence From Anesthesia in Anterior Temporal Lobectomy and Amygdalohippocampectomy Patients
An observational study of Emergence From Anesthesia, run by Lashmi Venkatraghavan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergence From Anesthesia
- What is being tested?
- Emergence from Anesthesia
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Mar 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergence from anesthesia in anterior temporal lobectomy and amygdalohippocampectomy PATIENTS
Who may be able to join
- Adult patients above the age of 18 who are scheduled for elective anterior temporal lobectomy and amygdalohippocampectomy under General Anesthesia
Who cannot join
- Lack of informed consent Patients needing intensive care unit postoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emergence From Anesthesia
- Being tested
- Emergence from Anesthesia
- Keywords
- Emergence from Anesthesia, Anterior temporal lobectomy, Amygdalohippocampectomy, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergence from AnesthesiaOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumes of the Hippocampus, Thalamus and Amygdala
Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Emergence From AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lashmi Venkatraghavan
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor-investigator, Lashmi Venkatraghavan, University Health Network, Toronto
- Investigators
- Lashmi Venkatraghavan, MD, Principal investigator, Toronto Western Hospital/UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360098
- Sponsor's protocol ID
- UHN REB 14-8212 BE
- Status last verified
- Jul 2020
- First submitted
- 2 Feb 2015
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of the Pattern of Emergence From Anesthesia in Patients Undergoing Anterior Temporal Lobectomy and Amygdalohippocampectomy
- ClinicalTrials.gov ID
- NCT02360098
- Acronym / sponsor ID
- UHN REB 14-8212 BE
- Conditions
- Emergence From Anesthesia
- Keywords
- Emergence from Anesthesia, Anterior temporal lobectomy, Amygdalohippocampectomy, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lashmi VenkatraghavanUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergence from anesthesia in anterior temporal lobectomy and amygdalohippocampectomy PATIENTS
Key inclusion criteria (1 listed)
- Adult patients above the age of 18 who are scheduled for elective anterior temporal lobectomy and amygdalohippocampectomy under General Anesthesia
Key exclusion criteria (1 listed)
- Lack of informed consent Patients needing intensive care unit postoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergence from AnesthesiaThere 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. | Other | – |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lashmi Venkatraghavan, MD principal investigator
Toronto Western Hospital/UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence From Anesthesia, run by Lashmi Venkatraghavan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumes of the Hippocampus, Thalamus and Amygdala (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.