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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02895776
Other study ID # GTR_2015_23
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 22, 2015
Est. completion date January 2017

Study information

Verified date September 2017
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 28
Est. completion date January 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients undergoing thrombectomy for ischemic stroke

- age = 18 years old

Exclusion Criteria:

- patient already under general anesthesia

- general sedation required

- haemorrhagic softening diagnosed before the beginning of procedure

- patient refusal to participate in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary factors associated with a conversion from conscious sedation to general anesthesia recording of the procedures during anesthesia during therapy (day 1)
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