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

Ruptured Cerebral Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778723
• Other study ID #: MD /17.08.07
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 10, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Rupture
• Ruptured Cerebral Aneurysm

Intervention

Drug:
• Total intravenous anesthesia (TIVA)
Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion
• Inhalation Anesthesia
Sevoflurane at a concentration of 2-2.5%
• 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

Locations

Country	Name	City	State
Egypt	Sherif A Mousa	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Heart rate		Immediately before and every 30 min for 6 hour following start of surgery
Secondary	Mean arterial blood pressure		Immediately before and every 30 min for 6 hour following start of surgery
Secondary	Peripheral oxygen saturation		Immediately before and every 30 min for 6 hour following start of surgery
Secondary	Central venous pressure		Immediately before and every 30 min for 6 hour following start of surgery
Secondary	End tidal carbon dioxide tension		Immediately before and every 30 min for 6 hour following start of surgery
Secondary	Sedation score	- Postoperative level of sedation of all patients will be evaluated using Ramsay sedation scale	For 6 hours from induction of anesthesia
Secondary	Time for first analgesic request from extubation	Time for first analgesic request from extubation	For 6 hours from induction of anesthesia
Secondary	Duration of stay in intensive care unit		For 5 days after surgery