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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03778723
Enrollment
50
Registered
2018-12-19
Start date
2018-12-18
Completion date
2020-01-10
Last updated
2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ruptured Cerebral Aneurysm

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.

Interventions

Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion

DRUGInhalation Anesthesia

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Arterio-Jugular oxygen content differenceImmediately before and every 30 min for 6 hour following start of surgeryThe differences between arterial and jugular bulb oxygen contents
Estimated cerebral metabolic rate for O2 (eCMRO2)Immediately before and every 30 min for 6 hour following start of surgeryeCMRO2=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)Immediately before and every 30 min for 6 hour following start of surgeryCalculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
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

MeasureTime frameDescription
End tidal carbon dioxide tensionImmediately 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
Heart rateImmediately before and every 30 min for 6 hour following start of surgery
Duration of stay in intensive care unitFor 5 days after surgery
Time for first analgesic request from extubationFor 6 hours from induction of anesthesiaTime for first analgesic request from extubation
Mean arterial blood pressureImmediately 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
Central venous pressureImmediately before and every 30 min for 6 hour following start of surgery

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026