Awareness, AnesthesiaNCT04949815
Awake Craniotomy for Arteriovenous Malformation
An observational study of Awareness, Anesthesia and Arteriovenous Malformations, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Awareness, Anesthesia, Arteriovenous Malformations
- How many people
- 4 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2018to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of arteriovenous malformation in brain
- Awake craniotomy for surgical resection of arteriovenous malformation
Who cannot join
- Patients with incomplete records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Four patients' charts were retrospectively reviewed and neurological status before and after awake craniotomy was assessed to look for any deterioration.
- Conditions
- Awareness, Anesthesia, Arteriovenous Malformations
- Medical subject headings
- Intraoperative Awareness, Arteriovenous Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Apr 2018
- Primary completion20 Dec 2019
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awareness, AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S Ather Enam, MD PhD, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949815
- Sponsor's protocol ID
- 2019-1436-4508
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series; Awake Craniotomy for Brain Arteriovenous Malformation - Experience From a Tertiary Care Center in a Low- And Middle-Income Country
- ClinicalTrials.gov ID
- NCT04949815
- Acronym / sponsor ID
- 2019-1436-4508
- Conditions
- Awareness, Anesthesia, Arteriovenous Malformations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure.
Detailed description
Four patients' charts were retrospectively reviewed and neurological status before and after awake craniotomy was assessed to look for any deterioration.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of arteriovenous malformation in brain
- Awake craniotomy for surgical resection of arteriovenous malformation
Key exclusion criteria (1 listed)
- Patients with incomplete records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Awareness, Anesthesia and Arteriovenous Malformations, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.