Back to results

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

Primary Purpose

Ruptured Cerebral Aneurysm

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Total intravenous anesthesia (TIVA)

Inhalation Anesthesia

Rescue fentanyl

About this trial

This is an interventional supportive care trial for Ruptured Cerebral Aneurysm

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sherif A Mousa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Total intravenous anesthesia (TIVA)

Inhalation Anesthesia

Arm Description

Patients will receive total intravenous anesthesia using Propofol and Midazolam

Patients will receive Inhalation anesthesia using Sevoflurane

Outcomes

Primary Outcome Measures

Arterio-Jugular oxygen content difference

The differences between arterial and jugular bulb oxygen contents

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

Cerebral Extraction Rate of O2 (CEO2)

Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2

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.

Secondary Outcome Measures

Heart rate

Mean arterial blood pressure

Peripheral oxygen saturation

Central venous pressure

End tidal carbon dioxide tension

Sedation score

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

Time for first analgesic request from extubation

Duration of stay in intensive care unit

Full Information

NCT ID

NCT03778723

First Posted

December 16, 2018

Last Updated

September 2, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03778723

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 18, 2018 (Actual)

Primary Completion Date

December 15, 2019 (Actual)

Study Completion Date

January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ruptured Cerebral Aneurysm

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Total intravenous anesthesia (TIVA)

Arm Type

Experimental

Arm Description

Patients will receive total intravenous anesthesia using Propofol and Midazolam

Arm Title

Inhalation Anesthesia

Arm Type

Active Comparator

Arm Description

Patients will receive Inhalation anesthesia using Sevoflurane

Intervention Type

Drug

Intervention Name(s)

Total intravenous anesthesia (TIVA)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Inhalation Anesthesia

Intervention Description

Sevoflurane at a concentration of 2-2.5%

Intervention Type

Drug

Intervention Name(s)

Rescue fentanyl

Intervention Description

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 Outcome Measure Information:

Title

Arterio-Jugular oxygen content difference

Description

The differences between arterial and jugular bulb oxygen contents

Time Frame