Influence of Anaesthesia Type on Multiple Sclerosis Relapse

July 26, 2024 updated by: Varazdin General Hospital

Multiple Sclerosis Comparison of Relapse Incidence After General and Neuraxial Anesthesia: a Retrospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited. A possible relapse after neuraxial anesthesia, it is believed to be associated with local anesthetic's toxicity and concentration.

The aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.

Study Type

Observational

Enrollment (Actual)

56

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients (medical records) with incomplete data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Intravenous or volatile general anesthesia was preformed with different type of airway management (endotracheal tube, laryngeal mask and bag mask ventilation)
Neuraxial anaesthesia
Neuraxial anesthesia was administered using spinal or epidural injections of local anesthetic with or without opioid.
Procedure: Neuraxial anaesthesia
spinal or epidural injections of local anesthetic with or without opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple sclerosis relapse after 1 month
Time Frame: 1 month
Overall incidence of multiple sclerosis relapse after 1 month after anaesthesia
1 month
Multiple sclerosis relapse after 3 months
Time Frame: 3 months
Overall incidence of multiple sclerosis relapse after 3 months after anaesthesia
3 months
Multiple sclerosis relapse after 6 months
Time Frame: 6 months
Overall incidence of multiple sclerosis relapse after 6 months after anaesthesia
6 months
Multiple sclerosis relapse after 12 months
Time Frame: 12 months
Overall incidence of multiple sclerosis relapse after 12 months after anaesthesia
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Varazdin General Hospital

Investigators

  • Principal Investigator: Monika Kocman Panic, MD, Varazdin General Hospital, Varazdin, Croatia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

May 16, 2024

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03072024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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