Identification of Genetic Polymorphisms Related to Propofol Requirement and Recovery Through Genome-wide Association Study (GWAS) in Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population

March 14, 2019 updated by: Yonsei University
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 find SNPs associated with propofol recovery and response through genome-wide association study (GWAS) in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seung Ho Choi, MD
  • Phone Number: +82 2 2228-2427
  • Email: csho99@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
        • Contact:
          • Seung Ho Choi, MD
          • Phone Number: +82 2 2228-2427
          • Email: csho99@yuhs.ac

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Korean adult population undergoing propofol based total intravenous anesthesia for clipping of unruptured cerebral aneurysm

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not able to read, or understand the consent form
  • Ethnicity, other than Korean population
  • Patients refusal
  • Patients not to perform total intravenous anesthesia
  • Patients currently taking psychiatric medication

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

Cohorts and Interventions

Group / Cohort
Prospective Cohort
In adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm, investigator 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.
Retrospective Cohort
In previous study performed in adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm (NCT02700126, 4-2015-1195), investigator enrolled patients and collected 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of eye opening after stopping propofol infusion
Time Frame: Within one hour
When operation is finished, investigator will stop the intravenous infusion of propofol. Investigators will measure the time from when propofol infusion is stopped until eye opening and extubation, respectively. The measurement will be established within about one hour from end of surgery.
Within one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

March 2, 2017

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (ACTUAL)

March 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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