Supratentorial Brain Tumor SurgeryNCT02944175
Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium: Comparison Between Sugammadex Versus Neostigmine
A study testing Sugammadex and Neostigmine in people with Supratentorial Brain Tumor Surgery, run by Mansoura University.
Trial summary
Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and have adverse effects associated with stimulation of muscarinic receptors. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Supratentorial Brain Tumor Surgery
- What is being tested?
- Sugammadex and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 1 Oct 2019
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical class status I - III .
- Patients scheduled for elective supratentorial brain tumor resection
Who cannot join
- Severe uncompensated cardiac disease.
- Severe uncompensated respiratory disease.
- Severe uncompensated hepatic disease.
- Severe uncompensated renal disease.
- Morbidly obese patients.
- Documented hypersensitivity to one of the used drugs.
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- Surgery in sitting position
- Surgery in prone position
- Patients with altered level of consciousness.
- Pregnancy.
About this study
Official title: Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium Neuromuscular Blockade In Cases Of Supratentorial Tumors: A Comparative Study Between Sugammadex Versus Neostigmine
Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and have adverse effects associated with stimulation of muscarinic receptors. In addition, neostigmine cannot be used to reverse profound blockade.
Anesthetics may exert their effects on various facets of cerebral function such as cerebral metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling, intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical activity. The net result of all these effects of the anaesthetic agents combined with their systemic effects may prove beneficial or detrimental to an already diseased brain.
In neurosurgical patients, clear and rapid recovery is required to early assess the neurological status and to maintain the cerebral oxygenation and metabolism within the normal physiological values which may be saved by sugammadex.
Read the detailed description
The aim of this study is to compare Sugammadex versus neostigmine as a reversal to the neuromuscular blockade of rocuronium in patients undergoing supratentorial tumors resection. Comparison will include hemodynamics, respiratory effort and degree of sedation.
Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.
- Conditions
- Supratentorial Brain Tumor Surgery
- Being tested
- Sugammadex, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
At the end of surgery and when 2 responses were achieved on the TOF stimulation, Sugammadex 2 mg·kg-1 was administered intravenously in Group S
NeostigmineDrug
At the end of surgery and when 2 responses were achieved on the TOF stimulation neostigmine 0.05 mg·kg-1 + atropine 0.02 mg·kg-1 was administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs Receives: Drug: Sugammadex |
| Neostigmine | Active comparator | Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery of the train-of-four (TOF) ratio to 0.9
The time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9
Measured: For 1 hour after surgery
Secondary outcomes (15)
Arterio-Jugular oxygen content difference
Ca jO2 = CaO2-CjvO
Measured: For 6 hours after the start of surgery
Estimated cerebral metabolic rate for oxygen (eCMRO2)
eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where ……. Ca jO2 is arterio-jugular O2 content difference.
- PaCO2 is arterial CO2 tension
Measured: For 6 hours after the start of surgery
Cerebral Extraction Rate of Oxygen (CEO2)
Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Measured: For 6 hours after the start of surgery
Cerebral Blood Flow equivalent (CBFe)
Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference
Measured: For 6 hours after the start of surgery
Heart rate
Measured: For 6 hours after the start of surgery
Blood pressure
Measured: For 6 hours after the start of surgery
Central venous pressure
Measured: For 6 hours after the start of surgery
Peripheral oxygen saturation
Measured: For 6 hours after the start of surgery
End-tidal carbon dioxide tension
Measured: For 6 hours after the start of surgery
Sedation level
Measured: For 1 hour after extubation
Total dose of neuromuscular blockade used
Measured: For 6 hours after the start of surgery
Total dose of suggamadex or neostigmine used
Measured: For 30 min after the end of surgery
Cumulative opioids consumption
Measured: For 6 hours after the start of surgery
Recovery time (RT)
the time of restoration of neuromuscular conduction sufficient for extubation from stoppage of anaesthesia till the patient can obey commands
Measured: For 1 hour after surgery
Time between administration of sugammadex or neostigmine to recovery
Time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9
Measured: For 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startJul 2016
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supratentorial Brain Tumor SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif A Mousa, Study chair, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944175
- Sponsor's protocol ID
- MD ∕16.07.22
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2016
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium Neuromuscular Blockade In Cases Of Supratentorial Tumors: A Comparative Study Between Sugammadex Versus Neostigmine
- ClinicalTrials.gov ID
- NCT02944175
- Acronym / sponsor ID
- MD ∕16.07.22
- Conditions
- Supratentorial Brain Tumor Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 25 Oct 2016 (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.
Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and have adverse effects associated with stimulation of muscarinic receptors. In addition, neostigmine cannot be used to reverse profound blockade.
Anesthetics may exert their effects on various facets of cerebral function such as cerebral metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling, intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical activity. The net result of all these effects of the anaesthetic agents combined with their systemic effects may prove beneficial or detrimental to an already diseased brain.
In neurosurgical patients, clear and rapid recovery is required to early assess the neurological status and to maintain the cerebral oxygenation and metabolism within the normal physiological values which may be saved by sugammadex.
Detailed description
The aim of this study is to compare Sugammadex versus neostigmine as a reversal to the neuromuscular blockade of rocuronium in patients undergoing supratentorial tumors resection. Comparison will include hemodynamics, respiratory effort and degree of sedation.
Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: SugammadexPatients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs |
| Neostigmine | Active comparator | Drug: NeostigminePatients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical class status I - III .
- Patients scheduled for elective supratentorial brain tumor resection
Key exclusion criteria (10 listed)
- Severe uncompensated cardiac disease.
- Severe uncompensated respiratory disease.
- Severe uncompensated hepatic disease.
- Severe uncompensated renal disease.
- Morbidly obese patients.
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 |
|---|---|---|
| SugammadexAt the end of surgery and when 2 responses were achieved on the TOF stimulation, Sugammadex 2 mg·kg-1 was administered intravenously in Group S | Drug | Sugammadex |
| NeostigmineAt the end of surgery and when 2 responses were achieved on the TOF stimulation neostigmine 0.05 mg·kg-1 + atropine 0.02 mg·kg-1 was administered intravenously | Drug | Neostigmine |
Primary outcome
Time to recovery of the train-of-four (TOF) ratio to 0.9
Time frame: For 1 hour after surgery
The time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9
15 secondary outcomes
Arterio-Jugular oxygen content difference
Time frame: For 6 hours after the start of surgery
Estimated cerebral metabolic rate for oxygen (eCMRO2)
Time frame: For 6 hours after the start of surgery
Cerebral Extraction Rate of Oxygen (CEO2)
Time frame: For 6 hours after the start of surgery
Cerebral Blood Flow equivalent (CBFe)
Time frame: For 6 hours after the start of surgery
Heart rate
Time frame: For 6 hours after the start of surgery
Blood pressure
Time frame: For 6 hours after the start of surgery
Central venous pressure
Time frame: For 6 hours after the start of surgery
Peripheral oxygen saturation
Time frame: For 6 hours after the start of surgery
End-tidal carbon dioxide tension
Time frame: For 6 hours after the start of surgery
Sedation level
Time frame: For 1 hour after extubation
Total dose of neuromuscular blockade used
Time frame: For 6 hours after the start of surgery
Total dose of suggamadex or neostigmine used
Time frame: For 30 min after the end of surgery
Cumulative opioids consumption
Time frame: For 6 hours after the start of surgery
Recovery time (RT)
Time frame: For 1 hour after surgery
Time between administration of sugammadex or neostigmine to recovery
Time frame: For 1 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sherif A Mousa study chair
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with Supratentorial Brain Tumor Surgery, run by Mansoura University.
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 2 inclusion and 10 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Time to recovery of the train-of-four (TOF) ratio to 0.9 (time frame: For 1 hour after surgery). 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 19 Oct 2018.