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Impact of Genetic Polymorphism on Propofol Requirement and Recovery for Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population

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ClinicalTrials.gov Identifier: NCT02700126
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Because the importance of rapid recovery in neurosurgery with long operation time is emphasized recently, the choice and dose adjustment of anesthetics should be determined according to clinical and genetic factors. Recently, researches about genetic variations have been performed with single nucleotide polymorphism (SNP). The aim of this study is to determine SNPs associated with propofol recovery and response in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.

Condition or disease
Unruptured Cerebral Aneurysm

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : March 7, 2016
Actual Primary Completion Date : February 22, 2017
Actual Study Completion Date : February 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
Drug Information available for: Propofol

Group/Cohort
undergoing propofol based TIVA for clip
This study is an observational study performed in adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm. We will collect data regarding recovery after stopping propofol infusion (time for eye opening and extubation), propofol requirement during anesthesia maintenance, and propofol effect site concentration to achieve bispectral index 40 during anesthesia induction, without doing any interventions. Data collection will be established with just observing and recording values displayed in screens of monitoring devices, and reviewing patient charts.



Primary Outcome Measures :
  1. Time of eye opening after stopping propofol infusion [ Time Frame: within about one hour from end of surgery ]

Biospecimen Retention:   Samples With DNA
Blood obtained from enrolled patients before surgery


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean adult population undergoing propofol based total intravenous anesthesia for clipping of unruptured cerebral aneurysm.
Criteria

Inclusion Criteria:

1. Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm

Exclusion Criteria:

  1. patients not able to read, or understand the consent form
  2. ethnicity, other than Korean population
  3. patients refusal
  4. patients not to perform total intravenous anesthesia

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): NCT02700126


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02700126     History of Changes
Other Study ID Numbers: 4-2015-1195
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share data

Keywords provided by Yonsei University:
propofol
total intravenous anesthesia
cerebral aneurysm
single nucleotide polymorphism

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General