NCT04237675

Brief Summary

The aim of the study is to record any relapses during one year postoperatively in patients and parturients diagnosed with MS who received general or regional anesthesia

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress80%
Dec 2019Dec 2027

Study Start

First participant enrolled

December 20, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

8 years

First QC Date

January 19, 2020

Last Update Submit

January 19, 2020

Conditions

Multiple Sclerosis RelapseSurgeryAnesthesia

Outcome Measures

Primary Outcomes (1)

  • MS relapses

    number of relapses

    one year postoperatively

Study Arms (2)

regional anesthesia

Procedure: surgery and anesthesia

general anesthesia

Procedure: surgery and anesthesia

Interventions

surgery and anesthesiaPROCEDURE

patients with MS who received general or regional anesthesia for a surgery or labor

general anesthesiaregional anesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients or parturients with MS who received general or regional anesthesia for surgery or labor analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aretaieio Hospital, University of Athens

Athens, Attica, 11528, Greece

RECRUITING

Aretaieio Hospital

Athens, Greece

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, OperativeAnesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Chryssoula V Staikou, Assoc Prof

CONTACT

00302107780172c_staikou@yahoo.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 23, 2020

Study Start

December 20, 2019

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

GR(2)