An interventional study of Total intravenous anesthesia (TIVA) and Inhalation Anesthesia in Ruptured Cerebral Aneurysm, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-09-04.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
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.
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 114 are open to participants now.
This study's enrollment of 50 is below the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 182 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive total intravenous anesthesia using Propofol and Midazolam
Drug: Total intravenous anesthesia (TIVA) · Drug: Rescue fentanyl
Patients will receive Inhalation anesthesia using Sevoflurane
Drug: Inhalation Anesthesia · Drug: Rescue fentanyl
Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion
Sevoflurane at a concentration of 2-2.5%
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
Arterio-Jugular oxygen content difference
The differences between arterial and jugular bulb oxygen contents
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Immediately before and every 30 min for 6 hour following start of surgery
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
- Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale
Time frame: For 6 hours from induction of anesthesia
Time for first analgesic request from extubation
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Mansoura University