NCT02700126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2017

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

12 months

First QC Date

February 26, 2016

Last Update Submit

March 7, 2017

Conditions

Keywords

propofoltotal intravenous anesthesiacerebral aneurysmsingle nucleotide polymorphism

Outcome Measures

Primary Outcomes (1)

  • Time of eye opening after stopping propofol infusion

    within about one hour from end of surgery

Study Arms (1)

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.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, Seoul, 03722, South Korea

Location

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: 17555608BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood obtained from enrolled patients before surgery

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 7, 2016

Study Start

March 7, 2016

Primary Completion

February 22, 2017

Study Completion

February 22, 2017

Last Updated

March 10, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

no plan to share data

Locations