CraniotomyNCT05103735
Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
An observational study of Craniotomy and Seizures, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial summary
Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniotomy, Seizures, Dexmedetomidine
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2021to 11 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALL PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION SURGERY
Who may be able to join
- PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION (EXCLUDED E.G. SURGERY OF EPILEPSIA)
- INTRAOPERATIVE MONITORING (IOM) WITH ELECTROCORTICOGRAPHY
- AWAKE-AWAKE-AWAKE TECHNIQUE
Who cannot join
- AGE <18 YEARS OLD
- NON AWAKE-AWAKE-AWAKE TECHNIQUE
- ABSENCE OF IOM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation
Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters.
Neurosurgeon could be help by Intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. Propofol and remifentanyl have been largely used. Dexmedetomidine represents an alternative. However little is known about the role of dexmedetomidine on Intraoperative electrocorticography.
- Conditions
- Craniotomy, Seizures, Dexmedetomidine, Propofol, Remifentanil, Cerebral Tumor
- Being tested
- Propofol
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Remifentanil, Dexmedetomidine
awake neurosurgery under propofol-remifentanil sedation
| Study group | Role | What they receive |
|---|---|---|
| PROPOFOL-REMIFENTANYL | Awake craniotomy under propofol-remifentanil sedation. Propofol and remifentanyl was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure.
Propofol dosage: 0.2-2 mk/kg/h Remifentanyl dosage: 0.01-0.1 mcg/kg/min Receives: Drug: Propofol | |
| DEXMEDETOMIDINE | Awake craniotomy under dexmedetomidine sedation. Dexmedetomidine was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure. Dexmedetomidine dosage: 0.2-1 mcg/kg/h In this group, remifentanyl administration was allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEIZURE ACTIVITY
INCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.
Measured: DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start15 Sep 2021
- Primary completion10 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CraniotomyStudies 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
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristian Deana, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103735
- Sponsor's protocol ID
- CRANIO-UDINE
- Status last verified
- Jan 2023
- First submitted
- 21 Oct 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Deana C, Pez S, Ius T, Furlan D, Nilo A, Isola M, De Martino M, Mauro S, Verriello L, Lettieri C, Tomasino B, Valente M, Skrap M, Vetrugno L, Pauletto G. Effect of Dexmedetomidine versus Propofol on Intraoperative Seizure Onset During Awake Craniotomy: A Retrospective Study. World Neurosurg. 2023 Apr;172:e428-e437. doi: 10.1016/j.wneu.2023.01.046. Epub 2023 Jan 20.
PubMed 36682527
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation
- ClinicalTrials.gov ID
- NCT05103735
- Acronym / sponsor ID
- CRANIO-UDINE
- Conditions
- Craniotomy, Seizures, Dexmedetomidine, Propofol, Remifentanil, Cerebral Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 2 Nov 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.
Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters.
Neurosurgeon could be help by Intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. Propofol and remifentanyl have been largely used. Dexmedetomidine represents an alternative. However little is known about the role of dexmedetomidine on Intraoperative electrocorticography.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROPOFOL-REMIFENTANYL | – | Drug: PropofolAwake craniotomy under propofol-remifentanil sedation. Propofol and remifentanyl was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure. Propofol dosage: 0.2-2 mk/kg/h Remifentanyl dosage: 0.01-0.1 mcg/kg/min |
| DEXMEDETOMIDINE | – | –Awake craniotomy under dexmedetomidine sedation. Dexmedetomidine was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure. Dexmedetomidine dosage: 0.2-1 mcg/kg/h In this group, remifentanyl administration was allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALL PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION SURGERY
Key inclusion criteria (3 listed)
- PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION (EXCLUDED E.G. SURGERY OF EPILEPSIA)
- INTRAOPERATIVE MONITORING (IOM) WITH ELECTROCORTICOGRAPHY
- AWAKE-AWAKE-AWAKE TECHNIQUE
Key exclusion criteria (3 listed)
- AGE <18 YEARS OLD
- NON AWAKE-AWAKE-AWAKE TECHNIQUE
- ABSENCE OF IOM
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: Remifentanil, Dexmedetomidineawake neurosurgery under propofol-remifentanil sedation | Drug | PROPOFOL-REMIFENTANYL |
Primary outcome
SEIZURE ACTIVITY
Time frame: DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY
INCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.
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 31 Jan 2023.
- Results publication: PubMed 36682527Deana C, Pez S, Ius T, Furlan D, Nilo A, Isola M, De Martino M, Mauro S, Verriello L, Lettieri C, Tomasino B, Valente M, Skrap M, Vetrugno L, Pauletto G. Effect of Dexmedetomidine versus Propofol on Intraoperative Seizure Onset During Awake Craniotomy: A Retrospective Study. World Neurosurg. 2023 Apr;172:e428-e437. doi: 10.1016/j.wneu.2023.01.046. Epub 2023 Jan 20.
- Individual participant dataSharing planned: Yes
Related trials for Craniotomy
Recruiting
rTMS for Postoperative Brain Tumor Patients
Brain Tumors, Transcranial Magnetic Stimulation
Not yet recruiting
Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for Postoperative Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
Craniotomy Surgery
Active, not recruitingObservational study
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Aneurysmal Subarachnoid Hemorrhage, Endovascular Procedures
Recruiting
Perioperative Multimodal Analgesia for Supratentorial Craniotomy
Postoperative Pain, Analgesia
Recruiting
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Brain Tumor, Brain Cancer
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 Craniotomy and Seizures, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
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 3 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 31 Jan 2023. 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 Italy. 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?
SEIZURE ACTIVITY (time frame: DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103735, which also lists 1 linked publication.
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 31 Jan 2023.