Awake Craniotomy for Brain Tumour SurgeryNCT00992940
Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy
A study of Awake Craniotomy for Brain Tumour Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Awake craniotomy for removal of brain tumour is performed because the tumour may be located close to areas of the brain that control specific functions such as movement or speech. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awake Craniotomy for Brain Tumour Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients more than 18 years of age
- ASA I, II or III
- Scheduled to undergo awake craniotomy for elective supratentorial tumor resection.
Who cannot join
- patients with allergy to the drugs being used.
- patients at risk for pulmonary aspiration eg patients with history of GERD, gastroparesis (eg diabetic) and obesity.
- patients with BMI 35 or above
- patients with severe cardiovascular or respiratory diseases (ASA IV or higher).
- patients who are pregnant.
- patients with alcohol or substance abuse.
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- patients who could not understand the concept of PCSA.
- patients who do not understand and are unable to follow instructions for the study due to a language barrier
- lack of informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
Official title: A Comparison of Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy for Tumor Surgery
Awake craniotomy for removal of brain tumour is performed because the tumour may be located close to areas of the brain that control specific functions such as movement or speech. Local anaesthesia (freezing) and sedation are required to make the patient comfortable and free of pain, but also to be able to cooperate for testing of brain function (speaking, moving) in order to preserve these areas while removing the brain tumour. The patient will be administered routine anesthetic drugs (sedatives (propofol) and pain killers (remifentanil)). The amount of sedation and analgesia (pain killer) is individually tailored to each patient as each person has different requirements. The usual way to give these medications is by the anesthesiologist assessing pain level, watching the patient and monitoring blood pressure and heart rate. Another way to give this medication is now available. This is with a special device, known as a patient-controlled analgesia pump (PCA). This device allows the patient to push a button to give pain medicine through an intravenous line and is frequently used for pain treatment after surgery and for other types of procedures. This device may be helpful during awake craniotomy, as it would allow patient-controlled administration of pain medicine and relaxing medicine whenever required. The amount of medication can be increased by more presses of the pump. At all times during the operation, the anesthesiologist will monitor the patient.
- Being tested
- Patient-Controlled Sedation/Analgesia, Anesthetist-Controlled Sedation/Analgesia
- Keywords
- awake craniotomy, patient-controlled sedation analgesia, anesthetist-controlled sedation analgesia, remifentanil-propofol, tumour surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Controlled Sedation/AnalgesiaProcedure or surgery
Patient controls delivery of sedation and analgesia requirements.
Anesthetist-Controlled Sedation/AnalgesiaProcedure or surgery
All sedation and analgesia requirements are determined and delivered by the attending anesthetist.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Controlled Sedation/Analgesia | Experimental | Patient controls the amount of sedation and analgesia delivered, according to their own requirements. Receives: Procedure: Patient-Controlled Sedation/Analgesia |
| Anesthetist-Controlled Sedation/Analgesia | Active comparator | Patient sedation and analgesia requirements are delivered by the anesthetist. Receives: Procedure: Anesthetist-Controlled Sedation/Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of patient-controlled sedation/analgesia remifentanil-propofol to maintain appropriate levels of sedation and analgesia in commensuration with the needs of the surgery at different stages.
Measured: 2 hours, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
Why it stopped: Funds needed to carry on the project were not secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake Craniotomy for Brain Tumour SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pirjo Manninen, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992940
- Sponsor's protocol ID
- 09-0492-A
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2009
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy for Tumor Surgery
- ClinicalTrials.gov ID
- NCT00992940
- Acronym / sponsor ID
- 09-0492-A
- Keywords
- awake craniotomy, patient-controlled sedation analgesia, anesthetist-controlled sedation analgesia, remifentanil-propofol, tumour surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funds needed to carry on the project were not secured.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- First posted
- 9 Oct 2009 (estimated)
- 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.
Awake craniotomy for removal of brain tumour is performed because the tumour may be located close to areas of the brain that control specific functions such as movement or speech. Local anaesthesia (freezing) and sedation are required to make the patient comfortable and free of pain, but also to be able to cooperate for testing of brain function (speaking, moving) in order to preserve these areas while removing the brain tumour. The patient will be administered routine anesthetic drugs (sedatives (propofol) and pain killers (remifentanil)). The amount of sedation and analgesia (pain killer) is individually tailored to each patient as each person has different requirements. The usual way to give these medications is by the anesthesiologist assessing pain level, watching the patient and monitoring blood pressure and heart rate. Another way to give this medication is now available. This is with a special device, known as a patient-controlled analgesia pump (PCA). This device allows the patient to push a button to give pain medicine through an intravenous line and is frequently used for pain treatment after surgery and for other types of procedures. This device may be helpful during awake craniotomy, as it would allow patient-controlled administration of pain medicine and relaxing medicine whenever required. The amount of medication can be increased by more presses of the pump. At all times during the operation, the anesthesiologist will monitor the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Controlled Sedation/Analgesia | Experimental | Procedure: Patient-Controlled Sedation/AnalgesiaPatient controls the amount of sedation and analgesia delivered, according to their own requirements. |
| Anesthetist-Controlled Sedation/Analgesia | Active comparator | Procedure: Anesthetist-Controlled Sedation/AnalgesiaPatient sedation and analgesia requirements are delivered by the anesthetist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients more than 18 years of age
- ASA I, II or III
- Scheduled to undergo awake craniotomy for elective supratentorial tumor resection.
Key exclusion criteria (9 listed)
- patients with allergy to the drugs being used.
- patients at risk for pulmonary aspiration eg patients with history of GERD, gastroparesis (eg diabetic) and obesity.
- patients with BMI 35 or above
- patients with severe cardiovascular or respiratory diseases (ASA IV or higher).
- patients who are pregnant.
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 |
|---|---|---|
| Patient-Controlled Sedation/AnalgesiaPatient controls delivery of sedation and analgesia requirements. | Procedure or surgery | Patient-Controlled Sedation/Analgesia |
| Anesthetist-Controlled Sedation/AnalgesiaAll sedation and analgesia requirements are determined and delivered by the attending anesthetist. | Procedure or surgery | Anesthetist-Controlled Sedation/Analgesia |
Primary outcome
To assess the ability of patient-controlled sedation/analgesia remifentanil-propofol to maintain appropriate levels of sedation and analgesia in commensuration with the needs of the surgery at different stages.
Time frame: 2 hours, 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
Related trials for Awake Craniotomy for Brain Tumour Surgery
Recruiting
The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.
Glioblastoma, Glioblastoma Multiforme
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.
Pirjo Manninen, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Awake Craniotomy for Brain Tumour Surgery, run by University Health Network, Toronto at 1 site in Canada.
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 9 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: withdrawn, as of the sponsor's last update on 9 Jan 2013. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
To assess the ability of patient-controlled sedation/analgesia remifentanil-propofol to maintain appropriate levels of sedation and analgesia in commensuration with the needs of the surgery at different stages. (time frame: 2 hours, 24 hours). 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 9 Jan 2013.