NCT06526130

Brief Summary

The influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited. The aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

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

January 1, 2012

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

11 years

First QC Date

July 23, 2024

Last Update Submit

July 26, 2024

Conditions

Keywords

Multiple Sclerosisanaesthesiarelapse

Outcome Measures

Primary Outcomes (4)

  • Multiple sclerosis relapse after 1 month

    Overall incidence of multiple sclerosis relapse after 1 month after anaesthesia

    1 month

  • Multiple sclerosis relapse after 3 months

    Overall incidence of multiple sclerosis relapse after 3 months after anaesthesia

    3 months

  • Multiple sclerosis relapse after 6 months

    Overall incidence of multiple sclerosis relapse after 6 months after anaesthesia

    6 months

  • Multiple sclerosis relapse after 12 months

    Overall incidence of multiple sclerosis relapse after 12 months after anaesthesia

    12 months

Study Arms (2)

General anaesthesia

Intravenous or volatile general anesthesia was preformed with different type of airway management (endotracheal tube, laryngeal mask and bag mask ventilation)

Procedure: General anaesthesia

Neuraxial anaesthesia

Neuraxial anesthesia was administered using spinal or epidural injections of local anesthetic with or without opioid.

Procedure: Neuraxial anaesthesia

Interventions

Intravenous or volatile general anesthesia was preformed with different type of airway management (endotracheal tube, laryngeal mask and bag mask ventilation)

General anaesthesia

spinal or epidural injections of local anesthetic with or without opioid

Neuraxial anaesthesia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study included adult patientswith multiple sclerosis diagnosis who had undergone general or neuraxial anesthesia in General Hospital Varaždin during the period from 01.01.2012 to 31.12.2022.

You may qualify if:

  • multiple sclerosis
  • surgical procedure under general anaesthesia
  • surgical procedure under neuraxial anaesthesia

You may not qualify if:

  • patients (medical records) with incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisRecurrence

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Monika Kocman Panic, MD

    Varazdin General Hospital, Varazdin, Croatia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 23, 2024

First Posted

July 29, 2024

Study Start

January 1, 2012

Primary Completion

December 31, 2022

Study Completion

May 16, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share