Cerebellopontine Angle TumorNCT04148534
Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery
A study testing Rocroniom, Non Depolarizing Muscle Relaxant in people with Cerebellopontine Angle Tumor, run by Muhammad Magdy Gaber at 1 site in Egypt.
Trial summary
compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery . To Estimate End to start facial nerve MEP amplitude ratio To determine the effect of neuromuscular relaxant degrees on recovery and Assessment of propofol… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cerebellopontine Angle Tumor
- What is being tested?
- Rocroniom, Non Depolarizing Muscle Relaxant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 15 Nov 2020
- 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
- Patients age between >18 and<60.
- Patients scheduled for neurosurgical CPA surgeries
- Ability to sign the consent
- ASA classification I, II
Who cannot join
- ASA > II
- Hemodynamically unstable
- Disease affecting neuromuscular transmission (myasthenia gravies ...etc.)
- GCS < 15.
- Any cardiac patient (ischemic heart disease - cardiomyopathy...etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block
compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery .
- To Estimate End to start facial nerve MEP amplitude ratio
- To determine the effect of neuromuscular relaxant degrees on recovery and
- Assessment of propofol doses needed for enhancement of early recovery and ambulation.
Read the detailed description
40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients will be one of two groups: Both Induction will be accomplished with fentanyl, propofol , rocronium infusion will be given randomly to one of the groups.
Depth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological monitoring will be done.
- Conditions
- Cerebellopontine Angle Tumor
- Being tested
- Rocroniom, Non Depolarizing Muscle Relaxant
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocroniom, Non Depolarizing Muscle RelaxantDrug
Also called Nerve stimulator for train of four assessment, BIS bispectral index
compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery
| Study group | Role | What they receive |
|---|---|---|
| muscle relaxant | Active comparator | patient who will receive muscle relaxant, patients will receive rocronium infusion by (5 mcg/kg/min) , maintain partial NMB TOF count 2 and targeting BIS = (40-60) Receives: Drug: Rocroniom, Non Depolarizing Muscle Relaxant |
| without muscle relaxant | Placebo comparator | patient who will not receive muscle relaxant, will recieve normal saline targeting BIS = 40-60. Receives: Drug: Rocroniom, Non Depolarizing Muscle Relaxant |
What is being measured
The primary outcome is the main question the study is designed to answer.
End to start facial nerve MEP amplitude ratio.
TCMEP recording will begin (1) prior to skin incision as baseline amplitude before muscle relaxant be taken for intubation (2) at Dural closure and end \start amplitude ratio will be calculated.
Measured: 6 to 8 month
Secondary outcomes (2)
number of hypotension episodes and the use of vasopressors
hemodynamic condition
Measured: 6 to 8 month
Total volume of propofol and fentanyl infused
Calculate dose consumption
Measured: 6 to 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Nov 2019
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellopontine Angle 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Magdy Gaber
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Muhammad Magdy Gaber, Cairo University
- Investigators
- Cairo university, Principal investigator, Cairo university faculty of medicine research ethical committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148534
- Sponsor's protocol ID
- D-4-2019
- Status last verified
- Jun 2022
- First submitted
- 25 Oct 2019
- Last updated
- 29 Jun 2022
- 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 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block
- ClinicalTrials.gov ID
- NCT04148534
- Acronym / sponsor ID
- D-4-2019
- Conditions
- Cerebellopontine Angle Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muhammad Magdy GaberUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 1 Nov 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.
compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery .
- To Estimate End to start facial nerve MEP amplitude ratio
- To determine the effect of neuromuscular relaxant degrees on recovery and
- Assessment of propofol doses needed for enhancement of early recovery and ambulation.
Detailed description
40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients will be one of two groups: Both Induction will be accomplished with fentanyl, propofol , rocronium infusion will be given randomly to one of the groups.
Depth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological monitoring will be done.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| muscle relaxant | Active comparator | Drug: Rocroniom, Non Depolarizing Muscle Relaxantpatient who will receive muscle relaxant, patients will receive rocronium infusion by (5 mcg/kg/min) , maintain partial NMB TOF count 2 and targeting BIS = (40-60) |
| without muscle relaxant | Placebo comparator | Drug: Rocroniom, Non Depolarizing Muscle Relaxantpatient who will not receive muscle relaxant, will recieve normal saline targeting BIS = 40-60. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age between >18 and<60.
- Patients scheduled for neurosurgical CPA surgeries
- Ability to sign the consent
- ASA classification I, II
Key exclusion criteria (5 listed)
- ASA > II
- Hemodynamically unstable
- Disease affecting neuromuscular transmission (myasthenia gravies ...etc.)
- GCS < 15.
- Any cardiac patient (ischemic heart disease - cardiomyopathy...etc.)
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 |
|---|---|---|
| Rocroniom, Non Depolarizing Muscle RelaxantAlso: Nerve stimulator for train of four assessment, BIS bispectral indexcompare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery | Drug | muscle relaxant, without muscle relaxant |
Primary outcome
End to start facial nerve MEP amplitude ratio.
Time frame: 6 to 8 month
TCMEP recording will begin (1) prior to skin incision as baseline amplitude before muscle relaxant be taken for intubation (2) at Dural closure and end \start amplitude ratio will be calculated.
2 secondary outcomes
number of hypotension episodes and the use of vasopressors
Time frame: 6 to 8 month
Total volume of propofol and fentanyl infused
Time frame: 6 to 8 month
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 29 Jun 2022.
- 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.
Cairo university principal investigator
Cairo university faculty of medicine research ethical committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocroniom, Non Depolarizing Muscle Relaxant in people with Cerebellopontine Angle Tumor, run by Muhammad Magdy Gaber at 1 site in Egypt.
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 4 inclusion and 5 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 29 Jun 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
End to start facial nerve MEP amplitude ratio. (time frame: 6 to 8 month). 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 29 Jun 2022.