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Completed

NCT Number: NCT03778723

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

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.

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Key information

Conditions

Ruptured Cerebral Aneurysm

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sherif A Mousa

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total intravenous anesthesia (TIVA)

Drug

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

Inhalation Anesthesia

Drug

Sevoflurane at a concentration of 2-2.5%

rescue fentanyl

Drug

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

Primary outcomes

  1. Arterio-Jugular oxygen content difference

    Time frame: Immediately before and every 30 min for 6 hour following start of surgery

    The differences between arterial and jugular bulb oxygen contents

  2. Estimated cerebral metabolic rate for O2 (eCMRO2)

    Time frame: 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

  3. Cerebral Extraction Rate of O2 (CEO2)

    Time frame: 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

  4. Cerebral Blood Flow equivalent (CBFe)

    Time frame: 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 outcomes

  1. Heart rate

    Time frame: Immediately before and every 30 min for 6 hour following start of surgery

  2. Mean arterial blood pressure

    Time frame: Immediately before and every 30 min for 6 hour following start of surgery

  3. Peripheral oxygen saturation

    Time frame: Immediately before and every 30 min for 6 hour following start of surgery

  4. Central venous pressure

    Time frame: Immediately before and every 30 min for 6 hour following start of surgery

  5. End tidal carbon dioxide tension

    Time frame: Immediately before and every 30 min for 6 hour following start of surgery

  6. Sedation score

    Time frame: For 6 hours from induction of anesthesia

    • Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale

  7. Time for first analgesic request from extubation

    Time frame: For 6 hours from induction of anesthesia

    Time for first analgesic request from extubation

  8. Duration of stay in intensive care unit

    Time frame: For 5 days after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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