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Effect of Propofol Midazolam on Cerebral Oxygenation and Metabolism During Clipping of Ruptured Cerebral Aneurysm

Not Applicable
Completed
Conditions
Ruptured Cerebral Aneurysm
Interventions
Drug: Total intravenous anesthesia (TIVA)
Drug: Inhalation Anesthesia
Drug: 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
Inclusion Criteria
  • American Society of Anesthesiologists physical status III or IV.
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Exclusion Criteria
  • 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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Total intravenous anesthesia (TIVA)Total intravenous anesthesia (TIVA)Patients will receive total intravenous anesthesia using Propofol and Midazolam
Total intravenous anesthesia (TIVA)Rescue fentanylPatients will receive total intravenous anesthesia using Propofol and Midazolam
Inhalation AnesthesiaInhalation AnesthesiaPatients will receive Inhalation anesthesia using Sevoflurane
Inhalation AnesthesiaRescue fentanylPatients will receive Inhalation anesthesia using Sevoflurane
Primary Outcome Measures
NameTimeMethod
Arterio-Jugular oxygen content differenceImmediately 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
NameTimeMethod
Mean arterial blood pressureImmediately before and every 30 min for 6 hour following start of surgery
End tidal carbon dioxide tensionImmediately before and every 30 min for 6 hour following start of surgery
Central venous pressureImmediately before and every 30 min for 6 hour following start of surgery
Sedation scoreFor 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 extubationFor 6 hours from induction of anesthesia

Time for first analgesic request from extubation

Heart rateImmediately before and every 30 min for 6 hour following start of surgery
Peripheral oxygen saturationImmediately before and every 30 min for 6 hour following start of surgery
Duration of stay in intensive care unitFor 5 days after surgery

Trial Locations

Locations (1)

Sherif A Mousa

🇪🇬

Mansourah, DK, Egypt

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