Supratentorial TumorNCT04691128
Desflurane and Brain Relaxation in Craniotomy
A study testing Desflurane and Propofol in people with Supratentorial Tumor, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Supratentorial Tumor
- What is being tested?
- Desflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2021to 31 Aug 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years
- Scheduled for elective craniotomy for supratentorial cerebral tumors
- ASA status I-III
- Glasgow score of 15
- No clinical signs of intracranial hypertension
- Preoperative brain imaging (CT or MRI) with midline shift less than 5mm
- Informed consent signed by patients
Who cannot join
- Scheduled intraoperative motor evoked potential monitoring
- Patients with cerebral vascular diseases
- Uncontrolled cardiopulmonary disease
- Schedule to retain tracheal intubation after surgery
- Unable to comprehend and cooperate with the examination
- BMI > 30 Kg/m-2
- Emergency surgery
- History of related anesthetic allergy
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy：a Randomized Controlled Study
Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.
Read the detailed description
To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.
- Conditions
- Supratentorial Tumor
- Being tested
- Desflurane, Propofol
- Medical subject headings
- Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called inhalational anesthesia
After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.
PropofolDrug
Also called TIVA, total intravenous anesthesia
After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Desflurane inhalational anesthesia | Experimental | Not described Receives: Drug: Desflurane |
| Propofol total intravenous anesthesia | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of satisfactory brain relaxation
Assessed by the neurosurgeon using a 4-point scale (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) at the opening of the dura mater, score 1 and 2 represent satisfactory brain relaxation
Measured: during surgery
Secondary outcomes (9)
Emergence time
from drug discontinuation to eye opening
Measured: from drug discontinuation to eye opening, assessed up to 1 hours
Extubation time
from drug discontinuation to tracheal extubation
Measured: from drug discontinuation to tracheal extubation, assessed up to 1 hours
Postoperative complications
incidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.
Measured: from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours
Postoperative pain and postoperative nausea and vomiting (PONV)
evaluated by Visual Analogue Score(VAS).
Measured: during the PACU stay and postoperative day 1.
Duration in PACU (Postanesthesia care unit)
time from entering PACU to exiting PACU
Measured: from entering PACU to exiting PACU, an expected average of 1 hour
Early postanesthesia cognitive recovery
evaluated by Short Orientation Memory Concentration Test (SOMCT)
Measured: at 15, 30min after tracheal extubation
Dural tension
evaluated using a 4-point scale after bone flap removal.
Measured: during surgery
Quality of anesthesia recovery
assessed by quality of recovery-15 scale (QoR-15)
Measured: at postoperative day 1
Anesthesia expenses
Total cost of anesthesia
Measured: at postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start26 Jan 2021
- Primary completion30 Aug 2021
- Study completion31 Aug 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 Supratentorial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691128
- Sponsor's protocol ID
- H199510180629
- Status last verified
- Oct 2021
- First submitted
- 12 Dec 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang Z, Wu Y, Liang F, Jian M, Liu H, Mei H, Han R. Brain relaxation using desflurane anesthesia and total intravenous anesthesia in patients undergoing craniotomy for supratentorial tumors: a randomized controlled study. BMC Anesthesiol. 2023 Jan 10;23(1):15. doi: 10.1186/s12871-023-01970-z.
PubMed 36624384
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy：a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04691128
- Acronym / sponsor ID
- H199510180629
- Conditions
- Supratentorial Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 31 Dec 2020 (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.
Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.
Detailed description
To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane inhalational anesthesia | Experimental | Drug: Desflurane |
| Propofol total intravenous anesthesia | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-60 years
- Scheduled for elective craniotomy for supratentorial cerebral tumors
- ASA status I-III
- Glasgow score of 15
- No clinical signs of intracranial hypertension
Key exclusion criteria (8 listed)
- Scheduled intraoperative motor evoked potential monitoring
- Patients with cerebral vascular diseases
- Uncontrolled cardiopulmonary disease
- Schedule to retain tracheal intubation after surgery
- Unable to comprehend and cooperate with the examination
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 |
|---|---|---|
| DesfluraneAlso: inhalational anesthesiaAfter induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil. | Drug | Desflurane inhalational anesthesia |
| PropofolAlso: TIVA, total intravenous anesthesiaAfter induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil | Drug | Propofol total intravenous anesthesia |
Primary outcome
Proportion of satisfactory brain relaxation
Time frame: during surgery
Assessed by the neurosurgeon using a 4-point scale (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) at the opening of the dura mater, score 1 and 2 represent satisfactory brain relaxation
9 secondary outcomes
Emergence time
Time frame: from drug discontinuation to eye opening, assessed up to 1 hours
Extubation time
Time frame: from drug discontinuation to tracheal extubation, assessed up to 1 hours
Postoperative complications
Time frame: from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours
Postoperative pain and postoperative nausea and vomiting (PONV)
Time frame: during the PACU stay and postoperative day 1.
Duration in PACU (Postanesthesia care unit)
Time frame: from entering PACU to exiting PACU, an expected average of 1 hour
Early postanesthesia cognitive recovery
Time frame: at 15, 30min after tracheal extubation
Dural tension
Time frame: during surgery
Quality of anesthesia recovery
Time frame: at postoperative day 1
Anesthesia expenses
Time frame: at postoperative day 1
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 26 Oct 2021.
- Derived from this study: PubMed 36624384Jiang Z, Wu Y, Liang F, Jian M, Liu H, Mei H, Han R. Brain relaxation using desflurane anesthesia and total intravenous anesthesia in patients undergoing craniotomy for supratentorial tumors: a randomized controlled study. BMC Anesthesiol. 2023 Jan 10;23(1):15. doi: 10.1186/s12871-023-01970-z.
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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?
A study testing Desflurane and Propofol in people with Supratentorial Tumor, run by Beijing Tiantan Hospital at 1 site in China.
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 7 inclusion and 8 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 26 Oct 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 China. 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?
Proportion of satisfactory brain relaxation (time frame: during surgery). 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 NCT04691128, 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 26 Oct 2021.