Awake Craniotomy for Arteriovenous Malformation

Arteriovenous Malformations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949815
• Other study ID #: 2019-1436-4508
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Awareness, Anesthesia
• Congenital Abnormalities
• Hemangioma
• Intraoperative Awareness

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