Clinical trial NCT03778723: Effect of Propofol Midazolam on Cerebral Oxygenation and Metabolism During Clipping of Ruptured Cerebral Aneurysm
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ruptured Cerebral Aneurysm
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status III or IV.

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.

Primary outcomes:
measure: Arterio-Jugular oxygen content difference
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Estimated cerebral metabolic rate for O2 (eCMRO2)
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Cerebral Extraction Rate of O2 (CEO2)
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Cerebral Blood Flow equivalent (CBFe)
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
Secondary outcomes:
measure: Heart rate
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Mean arterial blood pressure
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Peripheral oxygen saturation
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Central venous pressure
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: End tidal carbon dioxide tension
timeFrame: Immediately before and every 30 min for 6 hour following start of surgery
measure: Sedation score
timeFrame: For 6 hours from induction of anesthesia
measure: Time for first analgesic request from extubation
timeFrame: For 6 hours from induction of anesthesia
measure: Duration of stay in intensive care unit
timeFrame: For 5 days after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Sherif A Mousa
state: DK
Study officials:
affiliation: Professor
name: Sherif A Mousa, MD
role: STUDY_CHAIR
affiliation: Associate Professor
name: Mohammed A Ghanem, MD
role: STUDY_DIRECTOR
References: