Patients Undergoing Elective CraniotomyPhase 4NCT01985854
Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery
A Phase 4 study testing Propofol and Desflurane in people with Patients Undergoing Elective Craniotomy, run by Tokyo Women's Medical University at 1 site in Japan.
Trial summary
Since neurological testing during neurosurgery, such as somato-sensory evoked potentials, motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well maintained their wave-form reactivity with total intravenous anaesthesia technique better than inhalational anesthetic techniques, the… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Patients Undergoing Elective Craniotomy
- What is being tested?
- Propofol and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective craniotomy
- American Society of Anesthesiology Physical Status Ⅰ, II and III
- Age: between 20 to 65 years
- Sex: male or female
- Patients who are postmenopausal or surgically sterilized
- Expected Operation time is longer than 4 hours.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Japan1 site
Tokyo Women's Medical University Hospital
Tokyo, Tokyo, 1628666
Makoto Ozaki, Ph.D, 81-3-3353-8111 ext. 28290, mozaki@anes.twmu.ac.jp
Kasuya Yusuke, Ph.D, 81-3-3353-8111 ext. 29472, kasuyay@mb.infoweb.ne.jp
About this study
Official title: Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery: A Pilot Study for Assessment of Recovery Parameters
Since neurological testing during neurosurgery, such as somato-sensory evoked potentials, motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well maintained their wave-form reactivity with total intravenous anaesthesia technique better than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the evoked potential responses during surgery, facilitation of recovery from general anesthesia is getting important, because the real neurological physical examination is much more sensitive than above electrical evoked potentials to evaluate the results of surgical operation.
We propose to evaluate the recovery parameters after conversion from total intravenous anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The conversion will be initiated upon completion of the neurophysiological electric evoked potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize that recovery after conversion to Desflurane will be faster compared to recovery after total intravenous anaesthesia alone.
- Conditions
- Patients Undergoing Elective Craniotomy
- Being tested
- Propofol, Desflurane
- Keywords
- Desflurane, Propofol, Total intravenous anesthesia, Neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
DesfluraneDrug
Also called Suprane
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol target-controlled infusion will be kept 2-4μg /ml plasma concentration throughout procedure. Receives: Drug: Propofol |
| Desflurane | Experimental | After taking off the electrophysiological monitoring from the patients, discontinue propofol and start desflurane from 6% (dialed concentration) at flow rate of 4L/min for 2 minutes in desflurane group. When achieve end tidal concentration of 4-5%, decrease the flow rate to 2L/min. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the discontinuation of anesthesia to extubation
Measured: Patients will be followed in the operation room, an expected average of 30 minutes.
Secondary outcomes (3)
Time from the discontinuation of anesthesia to eye opening
Measured: At the end of surgery, duration time from the discontinuation of anesthesia to the eye opening will be measured, averaged expected time is 30 minutes
Cognitive function
Cognitive function will be measured by Mini-Mental state examination at baseline (preoperatively) 5 minutes and 24 hours after extubation. Postoperative recovery function will be also measured by Post-operative Quality Recovery Scale (PQRS scale) at 5 minutes and 24 hours after extubation.
Measured: Up to 24 hours
Time from the discontinuation of anesthesia to orientation
Time from the discontinuation of anesthesia to orientation (State name, state the date of birth)
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Elective 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Women's Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Makoto Ozaki, Tokyo Women's Medical University
- Investigators
- Makoto Ozaki, Ph.D, Study chair, Tokyo Women's Mecical University, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985854
- Sponsor's protocol ID
- TIVA DES conversion
- Status last verified
- Nov 2013
- First submitted
- 7 Oct 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery: A Pilot Study for Assessment of Recovery Parameters
- ClinicalTrials.gov ID
- NCT01985854
- Acronym / sponsor ID
- TIVA DES conversion
- Conditions
- Patients Undergoing Elective Craniotomy
- Keywords
- Desflurane, Propofol, Total intravenous anesthesia, Neurosurgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokyo Women's Medical UniversityUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 15 Nov 2013 (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.
Since neurological testing during neurosurgery, such as somato-sensory evoked potentials, motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well maintained their wave-form reactivity with total intravenous anaesthesia technique better than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the evoked potential responses during surgery, facilitation of recovery from general anesthesia is getting important, because the real neurological physical examination is much more sensitive than above electrical evoked potentials to evaluate the results of surgical operation.
We propose to evaluate the recovery parameters after conversion from total intravenous anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The conversion will be initiated upon completion of the neurophysiological electric evoked potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize that recovery after conversion to Desflurane will be faster compared to recovery after total intravenous anaesthesia alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolPropofol target-controlled infusion will be kept 2-4μg /ml plasma concentration throughout procedure. |
| Desflurane | Experimental | Drug: DesfluraneAfter taking off the electrophysiological monitoring from the patients, discontinue propofol and start desflurane from 6% (dialed concentration) at flow rate of 4L/min for 2 minutes in desflurane group. When achieve end tidal concentration of 4-5%, decrease the flow rate to 2L/min. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing elective craniotomy
- American Society of Anesthesiology Physical Status Ⅰ, II and III
- Age: between 20 to 65 years
- Sex: male or female
- Patients who are postmenopausal or surgically sterilized
Key exclusion criteria (1 listed)
- -
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: Diprivan | Drug | Propofol |
| DesfluraneAlso: Suprane | Drug | Desflurane |
Primary outcome
Time from the discontinuation of anesthesia to extubation
Time frame: Patients will be followed in the operation room, an expected average of 30 minutes.
3 secondary outcomes
Time from the discontinuation of anesthesia to eye opening
Time frame: At the end of surgery, duration time from the discontinuation of anesthesia to the eye opening will be measured, averaged expected time is 30 minutes
Cognitive function
Time frame: Up to 24 hours
Time from the discontinuation of anesthesia to orientation
Time frame: Up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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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.
Makoto Ozaki, Ph.D study chair
Tokyo Women's Mecical University, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Desflurane in people with Patients Undergoing Elective Craniotomy, run by Tokyo Women's Medical University at 1 site in Japan.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Nov 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Makoto Ozaki, Ph.D (81-3-3353-8111 ext. 28290, mozaki@anes.twmu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from the discontinuation of anesthesia to extubation (time frame: Patients will be followed in the operation room, an expected average of 30 minutes.). 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 15 Nov 2013.