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

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.

Study Overview

• Status: Completed
• Conditions: Ruptured Cerebral Aneurysm
• Intervention / Treatment: Drug: Total intravenous anesthesia (TIVA); Drug: Rescue fentanyl; Drug: Inhalation Anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Sherif A Mousa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total intravenous anesthesia (TIVA); Patients will receive total intravenous anesthesia using Propofol and Midazolam	Drug: Total intravenous anesthesia (TIVA); Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion; Drug: Rescue fentanyl; 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
Active Comparator: Inhalation Anesthesia; Patients will receive Inhalation anesthesia using Sevoflurane	Drug: Rescue fentanyl; 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; Drug: Inhalation Anesthesia; Sevoflurane at a concentration of 2-2.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterio-Jugular oxygen content difference	The differences between arterial and jugular bulb oxygen contents	Immediately before and every 30 min for 6 hour following start of surgery
Estimated cerebral metabolic rate for O2 (eCMRO2)	eCMRO2=Ca- jO2 x(PaCO2 ∕ 100), Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension	Immediately before and every 30 min for 6 hour following start of surgery
Cerebral Extraction Rate of O2 (CEO2)	Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2	Immediately before and every 30 min for 6 hour following start of surgery
Cerebral Blood Flow equivalent (CBFe)	: Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.	Immediately before and every 30 min for 6 hour following start of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate		Immediately before and every 30 min for 6 hour following start of surgery
Mean arterial blood pressure		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
Central venous 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
Sedation score	- Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale	For 6 hours from induction of anesthesia
Time for first analgesic request from extubation	Time for first analgesic request from extubation	For 6 hours from induction of anesthesia
Duration of stay in intensive care unit		For 5 days after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Sherif A Mousa, MD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 16, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics; Fentanyl
• Other Study ID Numbers: MD ∕17.08.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No