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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04949815
Other study ID # 2019-1436-4508
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date March 2, 2020

Study information

Verified date June 2021
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure.


Description:

Four patients' charts were retrospectively reviewed and neurological status before and after awake craniotomy was assessed to look for any deterioration.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date March 2, 2020
Est. primary completion date December 20, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Clinical diagnosis of arteriovenous malformation in brain - Awake craniotomy for surgical resection of arteriovenous malformation Exclusion Criteria: - Patients with incomplete records

Study Design


Locations

Country Name City State
Pakistan Aga Khan University Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in neurological status after surgery including GCS, cranial nerve functions and motor power in all four limbs (according to MRC scale). Comparison of pre-operative and post-operative neurological status to assess whether there was net improvement or deterioration. Pre-operative neurological status was assessed at the time of hospital admission and post-operative neurological status was assessed after 10 days of surgery. 10 days
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