Ruptured Cerebral AneurysmNCT03778723
Effect of Propofol Midazolam on Cerebral Oxygenation and Metabolism During Clipping of Ruptured Cerebral Aneurysm
A study testing Total intravenous anesthesia (TIVA), Inhalation Anesthesia and Rescue fentanyl in people with Ruptured Cerebral Aneurysm, run by Mansoura University at 1 site in Egypt.
Trial summary
Despite the theoretical benefits of i.v. 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 ICP were least with sevoflurane. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ruptured Cerebral Aneurysm
- What is being tested?
- Total intravenous anesthesia (TIVA), Inhalation Anesthesia and Rescue fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2018to 10 Jan 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 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.
Who cannot join
- Morbid obese patients.
- Severe or uncompensated cardiovascular diseases
- Severe or decompensated renal diseases
- Severe or decompensated hepatic diseases
- Severe or decompensated endocrinal diseases.
- Pregnancy
Show all 11Show fewer
- Postpartum
- Lactating females
- Allergy to one of the agents used.
- Severely altered consciousness level.
- Sitting or prone position during surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Oxygenation and Metabolism in Patients Undergoing Clipping of Cerebral Aneurysm: A Comparative Study Between Propofol-based Total Intravenous Anesthesia and Sevoflurane-based Inhalational Anesthesia
Despite the theoretical benefits of i.v. 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 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 hemodynamics and global cerebral oxygenation as well as the systemic hemodynamic changes using midazolam and propofol as total intravenous anesthetics (TIVA) in comparison with sevoflurane anesthesia in clipping of ruptured cerebral aneurysm.
- Conditions
- Ruptured Cerebral Aneurysm
- Being tested
- Total intravenous anesthesia (TIVA), Inhalation Anesthesia, Rescue fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total intravenous anesthesia (TIVA)Drug
Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion
Inhalation AnesthesiaDrug
Sevoflurane at a concentration of 2-2.5%
Rescue fentanylDrug
Fentanyl in repeated doses (50 µg) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value) are used for maintenance of analgesia
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia (TIVA) | Experimental | Patients will receive total intravenous anesthesia using Propofol and Midazolam Receives: Drug: Total intravenous anesthesia (TIVA); Drug: Rescue fentanyl |
| Inhalation Anesthesia | Active comparator | Patients will receive Inhalation anesthesia using Sevoflurane Receives: Drug: Inhalation Anesthesia; Drug: Rescue fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterio-Jugular oxygen content difference
The differences between arterial and jugular bulb oxygen contents
Measured: Immediately before and every 30 min for 6 hour following start of surgery
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 before and every 30 min for 6 hour following start of surgery
Cerebral Extraction Rate of O2 (CEO2)
Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Measured: Immediately before and every 30 min for 6 hour following 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. CBFe = 1 ∕CaO2-CjvO.
Measured: Immediately before and every 30 min for 6 hour following start of surgery
Secondary outcomes (8)
Heart rate
Measured: Immediately before and every 30 min for 6 hour following start of surgery
Mean arterial blood pressure
Measured: Immediately before and every 30 min for 6 hour following start of surgery
Peripheral oxygen saturation
Measured: Immediately before and every 30 min for 6 hour following start of surgery
Central venous pressure
Measured: Immediately before and every 30 min for 6 hour following start of surgery
End tidal carbon dioxide tension
Measured: Immediately before and every 30 min for 6 hour following start of surgery
Sedation score
- Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale
Measured: For 6 hours from induction of anesthesia
Time for first analgesic request from extubation
Time for first analgesic request from extubation
Measured: For 6 hours from induction of anesthesia
Duration of stay in intensive care unit
Measured: For 5 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 posted19 Dec 2018
- Study start18 Dec 2018
- Primary completion15 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Cerebral AneurysmStudies 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
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif A Mousa, MD, Study chair, ProfessorMohammed A Ghanem, MD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778723
- Sponsor's protocol ID
- MD ∕17.08.07
- Status last verified
- Sep 2020
- First submitted
- 16 Dec 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Metabolism in Patients Undergoing Clipping of Cerebral Aneurysm: A Comparative Study Between Propofol-based Total Intravenous Anesthesia and Sevoflurane-based Inhalational Anesthesia
- ClinicalTrials.gov ID
- NCT03778723
- Acronym / sponsor ID
- MD ∕17.08.07
- Conditions
- Ruptured Cerebral Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 19 Dec 2018 (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.
Despite the theoretical benefits of i.v. 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 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 hemodynamics and global cerebral oxygenation as well as the systemic hemodynamic changes using midazolam and propofol as total intravenous anesthetics (TIVA) in comparison with sevoflurane anesthesia in clipping of ruptured cerebral aneurysm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia (TIVA) | Experimental | Drug: Total intravenous anesthesia (TIVA), Drug: Rescue fentanylPatients will receive total intravenous anesthesia using Propofol and Midazolam |
| Inhalation Anesthesia | Active comparator | Drug: Inhalation Anesthesia, Drug: Rescue fentanylPatients will receive Inhalation anesthesia using Sevoflurane |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status III or IV.
Key exclusion criteria (11 listed)
- Morbid obese patients.
- Severe or uncompensated cardiovascular diseases
- Severe or decompensated renal diseases
- Severe or decompensated hepatic diseases
- Severe or decompensated 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 |
|---|---|---|
| Total intravenous anesthesia (TIVA)Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion | Drug | Total intravenous anesthesia (TIVA) |
| Inhalation AnesthesiaSevoflurane at a concentration of 2-2.5% | Drug | Inhalation Anesthesia |
| Rescue fentanylFentanyl in repeated doses (50 µg) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value) are used for maintenance of analgesia | Drug | Inhalation Anesthesia, Total intravenous anesthesia (TIVA) |
Primary outcome
Arterio-Jugular oxygen content difference
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
The differences between arterial and jugular bulb oxygen contents
Estimated cerebral metabolic rate for O2 (eCMRO2)
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
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 before and every 30 min for 6 hour following start of surgery
Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Cerebral Blood Flow equivalent (CBFe)
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
: 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: Immediately before and every 30 min for 6 hour following start of surgery
Mean arterial blood pressure
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
Peripheral oxygen saturation
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
Central venous pressure
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
End tidal carbon dioxide tension
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
Sedation score
Time frame: For 6 hours from induction of anesthesia
Time for first analgesic request from extubation
Time frame: For 6 hours from induction of anesthesia
Duration of stay in intensive care unit
Time frame: For 5 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 4 Sep 2020.
- 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, MD study chair
Professor
Mohammed A Ghanem, MD study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total intravenous anesthesia (TIVA), Inhalation Anesthesia and Rescue fentanyl in people with Ruptured Cerebral Aneurysm, run by Mansoura University 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 1 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 4 Sep 2020. 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. 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 before and every 30 min for 6 hour following start of surgery). 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 4 Sep 2020.