Effect of Propofol Midazolam on Cerebral Oxygenation and Metabolism During Clipping of Ruptured Cerebral Aneurysm
- Conditions
- Ruptured Cerebral Aneurysm
- Interventions
- Drug: Total intravenous anesthesia (TIVA)Drug: Inhalation AnesthesiaDrug: Rescue fentanyl
- Registration Number
- NCT03778723
- Lead Sponsor
- Mansoura University
- Brief 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- American Society of Anesthesiologists physical status III or IV.
- Morbid obese patients.
- Severe or uncompensated cardiovascular diseases
- Severe or decompensated renal diseases
- Severe or decompensated hepatic diseases
- Severe or decompensated endocrinal diseases.
- Pregnancy
- Postpartum
- Lactating females
- Allergy to one of the agents used.
- Severely altered consciousness level.
- Sitting or prone position during surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Total intravenous anesthesia (TIVA) Total intravenous anesthesia (TIVA) Patients will receive total intravenous anesthesia using Propofol and Midazolam Total intravenous anesthesia (TIVA) Rescue fentanyl Patients will receive total intravenous anesthesia using Propofol and Midazolam Inhalation Anesthesia Inhalation Anesthesia Patients will receive Inhalation anesthesia using Sevoflurane Inhalation Anesthesia Rescue fentanyl Patients will receive Inhalation anesthesia using Sevoflurane
- Primary Outcome Measures
Name Time Method Arterio-Jugular oxygen content difference Immediately before and every 30 min for 6 hour following start of surgery The differences between arterial and jugular bulb oxygen contents
Cerebral Extraction Rate of O2 (CEO2) 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
Estimated cerebral metabolic rate for O2 (eCMRO2) 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 Blood Flow equivalent (CBFe) 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.
- Secondary Outcome Measures
Name Time Method Mean arterial blood pressure Immediately before and every 30 min for 6 hour following start of surgery End tidal carbon dioxide tension Immediately before and every 30 min for 6 hour following start of surgery Central venous pressure Immediately before and every 30 min for 6 hour following start of surgery Sedation score For 6 hours from induction of anesthesia - Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale
Time for first analgesic request from extubation For 6 hours from induction of anesthesia Time for first analgesic request from extubation
Heart rate Immediately before and every 30 min for 6 hour following start of surgery Peripheral oxygen saturation Immediately before and every 30 min for 6 hour following start of surgery Duration of stay in intensive care unit For 5 days after surgery
Trial Locations
- Locations (1)
Sherif A Mousa
🇪🇬Mansourah, DK, Egypt