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

NCT03087383 | Unknown

• 1 other identifier: 4-2017-0008
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Unruptured Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

• Time of eye opening after stopping propofol infusion

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

• Iohom G, Ni Chonghaile M, O'Brien JK, Cunningham AJ, Fitzgerald DF, Shields DC. An investigation of potential genetic determinants of propofol requirements and recovery from anaesthesia. Eur J Anaesthesiol. 2007 Nov;24(11):912-9. doi: 10.1017/S0265021507000476. Epub 2007 Jun 7.

  PMID: 17555608 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood obtained from enrolled patients before surgery

Central Study Contacts

Seung Ho Choi, MD

CONTACT

+82 2 2228-2427; csho99@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 22, 2017
• Study Start: March 2, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)