Brain TumorNCT02575521
Effect of Propofol-Dexmedetomidine on Cerebral Oxygenation and Metabolism During Brain Tumor Resection
A study testing Propofol-Dexmedetomidine group and Sevoflurane group in people with Brain Tumor and Surgery, run by Mansoura University.
Trial summary
Despite theoretical benefits of intravenous agents, volatile agents remain popular. In a study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and intra-cranial pressure (ICP) were least with sevoflurane. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Brain Tumor, Surgery
- What is being tested?
- Propofol-Dexmedetomidine group and Sevoflurane group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 1 Nov 2017
- 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 status III or IV.
- Patients scheduled for elective brain tumor resection
Who cannot join
- Morbid obese patients.
- Severe or uncompensated cardiovascular diseases.
- Severe or uncompensated renal diseases.
- Severe or uncompensated hepatic diseases.
- Severe or uncompensated endocrinal diseases.
- Pregnancy.
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- Postpartum or lactating females.
- Allergy to one of the agents used.
- Severely altered consciousness level.
- Sitting position during surgery.
- Prone position during surgery,
About this study
Official title: Effect of Propofol-Dexmedetomidine Total Intravenous Anaesthesia on Cerebral Oxygenation and Metabolism During Brain Tumor Resection Compared to Sevoflurane Anaesthesia
Despite theoretical benefits of intravenous agents, volatile agents remain popular. In a study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and intra-cranial pressure (ICP) were least with sevoflurane.
Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.
The well known pharmacodynamic advantages of intravenous anesthetics may give this group of drugs superior cerebral effects when compared with inhalation anesthetics.
Read the detailed description
The aim of this study is to evaluate the cerebral haemodaynamics and global cerebral oxygenation as well as the systemic haemodaynamic changes using dexmedetomidine, propofol and fentanyl as total intravenous anaesthestics (TIVA) in comparison with sevoflurane - fentanyl anesthesia in brain tumor resection.
Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.
- Induction: propofol, 1.5 - 2 mg/kg.
- Muscle Relaxants: atracurium, 0.5 mg/kg with induction and 0.1 mg/kg/20min. for maintenance.
- Cannulation: Arterial cannula: under complete aseptic conditions 20G cannula was inserted into the radial artery of non dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2%.
Central venous catheter: A suitable central venous catheter will be inserted into Rt subclavian vein under complete aseptic technique, its correct position will be confirmed with chest X-Ray.
Jugular bulb catheterization: Under strict sterile technique the right internal jugular vein will be cannulated in a retrograde technique with confirmation of the catheter tip position using X-Ray (C- arm). Puncture site will be at the level of cricoid cartilage behind the anterior border of the sternocleido-mastoid muscle.
- Conditions
- Brain Tumor, Surgery
- Being tested
- Propofol-Dexmedetomidine group, Sevoflurane group
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol-Dexmedetomidine groupDrug
Porofol (1.5-2 mg/kg/h) infusion, Dexmedetomidine (0.2-1µg/kg/h) infusion and Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value). Maintenance infusions will start immediately after induction.
Sevoflurane groupDrug
Sevoflurane at a concentration of 2-2.5%., Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value).
| Study group | Role | What they receive |
|---|---|---|
| Propofol-Dexmedetomidine group | Placebo comparator | this group is planned to receive intravenous anaesthesia only Receives: Drug: Propofol-Dexmedetomidine group |
| Sevoflurane group | Active comparator | this group is planned to receive sevoflurane/fentanyl anaesthesia Receives: Drug: Sevoflurane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterio-Jugular oxygen content difference
Measured: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
Estimated cerebral metabolic rate for O2 (eCMRO2)
eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension
Measured: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
Cerebral Extraction Rate of O2 (CEO2)
Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Measured: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp.
Cerebral Blood Flow equivalent (CBFe)
Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.
Measured: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
Secondary outcomes (8)
Heart rate
Measured: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Blood pressure
Measured: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
End-tidal carbon dioxide tension
Measured: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Central venous pressure
Measured: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Postoperative level of sedation
all patients will be evaluated using Ramsay sedation scale
Measured: every 5 min for 60 min, after extubation
Time for first analgesic request from extubation
Measured: for 6 hours after surgery
Total analgesics received
Measured: for 24 hours after surgery
Intensive care unit stay
Measured: for 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed A. Daif, MD, Principal investigator, Anaesthesia and Intensive Care Department, College of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575521
- Sponsor's protocol ID
- MFM-IRB-14-08-2015
- Status last verified
- Nov 2017
- First submitted
- 7 Oct 2015
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol-Dexmedetomidine Total Intravenous Anaesthesia on Cerebral Oxygenation and Metabolism During Brain Tumor Resection Compared to Sevoflurane Anaesthesia
- ClinicalTrials.gov ID
- NCT02575521
- Acronym / sponsor ID
- MFM-IRB-14-08-2015
- Conditions
- Brain Tumor, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 14 Oct 2015 (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.
Despite theoretical benefits of intravenous agents, volatile agents remain popular. In a study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and intra-cranial pressure (ICP) were least with sevoflurane.
Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.
The well known pharmacodynamic advantages of intravenous anesthetics may give this group of drugs superior cerebral effects when compared with inhalation anesthetics.
Detailed description
The aim of this study is to evaluate the cerebral haemodaynamics and global cerebral oxygenation as well as the systemic haemodaynamic changes using dexmedetomidine, propofol and fentanyl as total intravenous anaesthestics (TIVA) in comparison with sevoflurane - fentanyl anesthesia in brain tumor resection.
Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.
- Induction: propofol, 1.5 - 2 mg/kg.
- Muscle Relaxants: atracurium, 0.5 mg/kg with induction and 0.1 mg/kg/20min. for maintenance.
- Cannulation: Arterial cannula: under complete aseptic conditions 20G cannula was inserted into the radial artery of non dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2%.
Central venous catheter: A suitable central venous catheter will be inserted into Rt subclavian vein under complete aseptic technique, its correct position will be confirmed with chest X-Ray.
Jugular bulb catheterization: Under strict sterile technique the right internal jugular vein will be cannulated in a retrograde technique with confirmation of the catheter tip position using X-Ray (C- arm). Puncture site will be at the level of cricoid cartilage behind the anterior border of the sternocleido-mastoid muscle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol-Dexmedetomidine group | Placebo comparator | Drug: Propofol-Dexmedetomidine groupthis group is planned to receive intravenous anaesthesia only |
| Sevoflurane group | Active comparator | Drug: Sevoflurane groupthis group is planned to receive sevoflurane/fentanyl anaesthesia |
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 status III or IV.
- Patients scheduled for elective brain tumor resection
Key exclusion criteria (11 listed)
- Morbid obese patients.
- Severe or uncompensated cardiovascular diseases.
- Severe or uncompensated renal diseases.
- Severe or uncompensated hepatic diseases.
- Severe or uncompensated endocrinal diseases.
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 |
|---|---|---|
| Propofol-Dexmedetomidine groupPorofol (1.5-2 mg/kg/h) infusion, Dexmedetomidine (0.2-1µg/kg/h) infusion and Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value). Maintenance infusions will start immediately after induction. | Drug | Propofol-Dexmedetomidine group |
| Sevoflurane groupSevoflurane at a concentration of 2-2.5%., Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value). | Drug | Sevoflurane group |
Primary outcome
Arterio-Jugular oxygen content difference
Time frame: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
Estimated cerebral metabolic rate for O2 (eCMRO2)
Time frame: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension
Cerebral Extraction Rate of O2 (CEO2)
Time frame: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp.
Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Cerebral Blood Flow equivalent (CBFe)
Time frame: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.
8 secondary outcomes
Heart rate
Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Blood pressure
Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
End-tidal carbon dioxide tension
Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Central venous pressure
Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Postoperative level of sedation
Time frame: every 5 min for 60 min, after extubation
Time for first analgesic request from extubation
Time frame: for 6 hours after surgery
Total analgesics received
Time frame: for 24 hours after surgery
Intensive care unit stay
Time frame: for 10 days after surgery
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 8 Nov 2017.
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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.
Ahmed A. Daif, MD principal investigator
Anaesthesia and Intensive Care Department, College of Medicine, Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing Propofol-Dexmedetomidine group and Sevoflurane group in people with Brain Tumor and 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 11 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 8 Nov 2017. 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. 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?
Arterio-Jugular oxygen content difference (time frame: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp). The study lists 4 primary outcomes in all. 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 8 Nov 2017.