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Emergence From Anesthesia in Anterior Temporal Lobectomy and Amygdalohippocampectomy Patients

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ClinicalTrials.gov Identifier: NCT02360098
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Lashmi Venkatraghavan, University Health Network, Toronto

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. 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.

Condition or disease Intervention/treatment
Emergence From Anesthesia Other: Emergence from Anesthesia

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of the Pattern of Emergence From Anesthesia in Patients Undergoing Anterior Temporal Lobectomy and Amygdalohippocampectomy
Study Start Date : December 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Intervention Details:
  • Other: Emergence from Anesthesia
    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.


Primary Outcome Measures :
  1. Pattern of Emergence of Anesthesia [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Glasgow coma scale( GCS) [ Time Frame: 1 day ]
  2. Riker agitation- sedation score [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergence from anesthesia in anterior temporal lobectomy and amygdalohippocampectomy PATIENTS
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360098


Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
Lashmi Venkatraghavan
University Health Network, Toronto

Responsible Party: Lashmi Venkatraghavan, Assistant Professor, Department of Anesthesia, Toronto Western Hospital, Toronto, Canada, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02360098     History of Changes
Other Study ID Numbers: UHN REB 14-8212 BE
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Lashmi Venkatraghavan, University Health Network, Toronto:
Emergence from Anesthesia
Anterior temporal lobectomy
Amygdalohippocampectomy
Anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs