Awake Craniotomy for Arteriovenous Malformation

June 25, 2021 updated by: S Ather Enam, MD PhD, Aga Khan University

Case Series; Awake Craniotomy for Brain Arteriovenous Malformation - Experience From a Tertiary Care Center in a Low- And Middle-Income Country

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74500
        • Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients, irrespective of age and gender, who underwent awake craniotomy under scalp block for resection of brain AVMs at our hospital were reviewed.

Description

Inclusion Criteria:

  • Clinical diagnosis of arteriovenous malformation in brain
  • Awake craniotomy for surgical resection of arteriovenous malformation

Exclusion Criteria:

  • Patients with incomplete records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neurological status after surgery including GCS, cranial nerve functions and motor power in all four limbs (according to MRC scale).
Time Frame: 10 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

March 2, 2020

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1436-4508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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