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

NCT ID: NCT03778723

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2020-01-10

Brief Summary

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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

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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.

Conditions

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Ruptured Cerebral Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Total intravenous anesthesia (TIVA)

Patients will receive total intravenous anesthesia using Propofol and Midazolam

Group Type EXPERIMENTAL

Total intravenous anesthesia (TIVA)

Intervention Type DRUG

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

Rescue fentanyl

Intervention Type 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

Inhalation Anesthesia

Patients will receive Inhalation anesthesia using Sevoflurane

Group Type ACTIVE_COMPARATOR

Inhalation Anesthesia

Intervention Type DRUG

Sevoflurane at a concentration of 2-2.5%

Rescue fentanyl

Intervention Type 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

Interventions

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Total intravenous anesthesia (TIVA)

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

Intervention Type DRUG

Inhalation Anesthesia

Sevoflurane at a concentration of 2-2.5%

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherif A Mousa, MD

Role: STUDY_CHAIR

Professor

Mohammed A Ghanem, MD

Role: STUDY_DIRECTOR

Associate Professor

Locations

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Sherif A Mousa

Al Mansurah, DK, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD ∕17.08.07

Identifier Type: -

Identifier Source: org_study_id

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