Risk Factors of Conversion From Local to General Sedation in Endovascular Stroke Therapy

NCT02895776 | Terminated

• 1 other identifier: GTR_2015_23
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation. The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures every year. We report a rate of 5% of these procedures requiring general anesthesia despite conscious sedation being the standard of care. This study aims to identify clinical factors associated with a risk of conversion of a conscious sedation to a general anesthesia.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• factors associated with a conversion from conscious sedation to general anesthesia

  recording of the procedures during anesthesia

  during therapy (day 1)

Study Arms (2)

General Sedation

Case patients: Endovascular Acute Stroke Therapy scheduled to be performed under local sedation and finally performed under General anesthesia

local sedation

Control patients: Endovascular Acute Stroke Therapy scheduled to be performed, and actually performed under conscious Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Endovascular Acute Stroke Therapy scheduled to be performed with local sedation and either performed under General Anesthesia (case), either actually performed under conscious sedation (control). Endovascular Acute Stroke Therapy scheduled to be performed with conscious sedation and performed under General Anesthesia 3 control patients will be included per case, and matched with the moment of procedure (term of the year).

You may qualify if:

• patients undergoing thrombectomy for ischemic stroke
• age ≥ 18 years old

You may not qualify if:

• patient already under general anesthesia
• general sedation required
• haemorrhagic softening diagnosed before the beginning of procedure
• patient refusal to participate in the study

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: December 22, 2015
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 9, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)