NCT03123302

Brief Summary

In this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after MRI scanning with sedation. This is a retrospective, single center observational study. All patients undergoing MRI scan during the study period will be included.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
977

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

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

Study Start

First participant enrolled

February 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

April 18, 2017

Last Update Submit

June 2, 2020

Conditions

Epileptic SeizureIntracranial TumorIntracranial HypertensionIntracranial AneurysmVertebra; Anomaly

Keywords

MRI scan, sedation, epilepsia

Outcome Measures

Primary Outcomes (1)

  • Patient characteristics anesthesia choice and possible complications during MRI anesthesia.

    To investigate the influence of patient characteristics and anesthesia choice on possible complications of sedation anesthesia during MRI scanning

    1 week

Study Arms (4)

Group 1

Epileptic patients who are sedated with a total dose of propofol 2 mg/kg and midazolam 0.1 mg/kg.

Group 2

Epileptic patients who are sedated with a total dose of pentothal 4 mg/kg and midazolam 0.1 mg/kg.

Group 3

Non-epileptic patients who are sedated with a total dose of propofol 1 mg/kg and ketamine 1 mg/kg.

Group 4

Non-epileptic patients who are sedated with a total dose of midazolame 0.1 mg/kg and ketamine 1 mg/kg.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing MRI scan wth sedation anesthesia and giving written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AkdenizU

Antalya, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SeizuresBrain NeoplasmsIntracranial HypertensionIntracranial AneurysmCongenital AbnormalitiesEpilepsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersAneurysmVascular DiseasesCardiovascular DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ilker O Aycan, MD

    Akdeniz University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of anesthesiology and reanimation

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 21, 2017

Study Start

February 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 8, 2018

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

TU(1)