- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526130
Influence of Anaesthesia Type on Multiple Sclerosis Relapse
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
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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)
|
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.
|
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
Sponsor
Investigators
- Principal Investigator: Monika Kocman Panic, MD, Varazdin General Hospital, Varazdin, Croatia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Disease Attributes
- Multiple Sclerosis
- Sclerosis
- Recurrence
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- 03072024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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