Brain TumorNCT03910556
Re-craniotomy and Complications After Elective Neurosurgery
An observational study of Brain Tumor and Brain Metastases, run by Chiang Mai University.
Trial summary
This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Tumor, Brain Metastases, Brain Cancer
- What is being tested?
- Propofol
- How many people
- 439 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Feb 2019
- How long will I take part?
- 2 Days
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The adult patients who were scheduled for craniotomy to remove tumor
Who may be able to join
- Patients who are scheduled for elective craniotomy during 2017-2019
- Patients who are planned for general anesthesia
- Patients have read the study information and signed in the consent form
Who cannot join
- Patients who are unable to understand and sign in the consent form
- Patients who are scheduled for minor surgical procedures such as ventriculostomy and VP-shunt
About this study
Official title: Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study
This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.
Read the detailed description
Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation.
Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation.
Postoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.
- Conditions
- Brain Tumor, Brain Metastases, Brain Cancer, Brain Neoplasms
- Being tested
- Propofol
- Keywords
- re-craniotomy, major non-neurological complications, neurosurgery, brain tumors
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called surgical duration, operation, blood loss, blood used
intraoperative factors
| Study group | Role | What they receive |
|---|---|---|
| no complication | the patients who did not develop any kind of complication and no re-craniotomy Receives: Drug: Propofol | |
| with complication (s) | the patients who developed at least one of non-neurological complication or required re-craniotomy Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-craniotomy
number of participants who required re-craniotomy assessed by the neurosurgeon
Measured: the first 24 hours
predictive factors of re-craniotomy
types of perioperative factors to predict the occurrence of re-craniotomy
Measured: the first 24 hours
Secondary outcomes (2)
incidence of major non-neurological complications
number of participants who develop any major systemic complications
Measured: the first 24 hours
predictive factors of major non-neurological complications
types of predictive factors to predict the occurrence of major non-neurological complications
Measured: the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study startJan 2017
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 439 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- Yodying Punjasawadwong, Prangmalee Leucharussamee, Ananchanok Saringkarinkul, Patipan Krungsri
- Responsible party
- Principal investigator, Pathomporn Pin on, M.D., Chiang Mai University
- Investigators
- Pathomporn Pin-on, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910556
- Sponsor's protocol ID
- ANE-2561-05961
- Status last verified
- Apr 2019
- First submitted
- 6 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03910556
- Acronym / sponsor ID
- ANE-2561-05961
- Conditions
- Brain Tumor, Brain Metastases, Brain Cancer, Brain Neoplasms
- Keywords
- re-craniotomy, major non-neurological complications, neurosurgery, brain tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- Yodying Punjasawadwong, Prangmalee Leucharussamee, Ananchanok Saringkarinkul, Patipan Krungsri
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 10 Apr 2019 (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.
This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.
Detailed description
Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation.
Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation.
Postoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no complication | – | Drug: Propofolthe patients who did not develop any kind of complication and no re-craniotomy |
| with complication (s) | – | Drug: Propofolthe patients who developed at least one of non-neurological complication or required re-craniotomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The adult patients who were scheduled for craniotomy to remove tumor
Key inclusion criteria (3 listed)
- Patients who are scheduled for elective craniotomy during 2017-2019
- Patients who are planned for general anesthesia
- Patients have read the study information and signed in the consent form
Key exclusion criteria (2 listed)
- Patients who are unable to understand and sign in the consent form
- Patients who are scheduled for minor surgical procedures such as ventriculostomy and VP-shunt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: surgical duration, operation, blood loss, blood usedintraoperative factors | Drug | no complication, with complication (s) |
Primary outcome
re-craniotomy
Time frame: the first 24 hours
number of participants who required re-craniotomy assessed by the neurosurgeon
predictive factors of re-craniotomy
Time frame: the first 24 hours
types of perioperative factors to predict the occurrence of re-craniotomy
2 secondary outcomes
incidence of major non-neurological complications
Time frame: the first 24 hours
predictive factors of major non-neurological complications
Time frame: the first 24 hours
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 12 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Pathomporn Pin-on, MD principal investigator
Chiang Mai University
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Brain Metastases, run by Chiang Mai University.
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 3 inclusion and 2 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
re-craniotomy (time frame: the first 24 hours). The study lists 2 primary outcomes in all. 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 12 Apr 2019.