Clincosm LogoSign in Get a demo

Our Anesthesia Experience During MRI Scan

Sponsor
Akdeniz University (Other)
Overall Status
Completed
CT.gov ID
NCT03123302
Collaborator
(none)
977
Enrollment
1
Location
12.2
Actual Duration (Months)
79.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this study we aim to investigate the influence of patient characteristics and anesthesia choice on possible complications in patients undergoing MRI under sedation retrospectively.

    After one of the routine sedation protocol used in our department was chosen and applied according to the physical status of the patient and the physicians decision, the datas of the patients will be recruited to the study from the medical records . Patient characteristics (age, gender, weight, height), ASA (American Society of Anethesiology) classification, associated diseases will be recorded . After the procedure was completed all the complications during the 2 hours waiting period in the recovery room will be recorded from the medical records. All the complşcation and recovery times will be recorded from the medical records. Whether the patient received radiocontrast material or not will also be recorded. The patients will be called by phone, and will be questioned for the complications, any epileptic seizure attack, or increase in the number of seizures, any admission to emergency room or any in patient admission to the hospital will be recorded which developed in the first week after the procedure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    977 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Our Anesthesia Experience During MRI Scan
    Actual Study Start Date :
    Feb 1, 2017
    Actual Primary Completion Date :
    Feb 1, 2018
    Actual Study Completion Date :
    Feb 8, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Patient characteristics anesthesia choice and possible complications during MRI anesthesia. [1 week]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    Exclusion Criteria: patients refusal to be studied.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AkdenizU Antalya Turkey 07058

    Sponsors and Collaborators

    • Akdeniz University

    Investigators

    • Principal Investigator: Ilker O Aycan, MD, Akdeniz University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    İlker Onguc Aycan, department of anesthesiology and reanimation, Akdeniz University
    ClinicalTrials.gov Identifier:
    NCT03123302
    Other Study ID Numbers:
    • MEDAH
    First Posted:
    Apr 21, 2017
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by İlker Onguc Aycan, department of anesthesiology and reanimation, Akdeniz University
    MRI scan, sedation, epilepsia
    Additional relevant MeSH terms:
    Seizures
    Intracranial Aneurysm
    Epilepsy
    Intracranial Hypertension
    Aneurysm

    Study Results

    No Results Posted as of Jun 4, 2020