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

NCT03778723 | Completed DMC

• 1 other identifier: MD ∕17.08.07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ruptured Cerebral Aneurysm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (2)

Total intravenous anesthesia (TIVA)

EXPERIMENTAL

Patients will receive total intravenous anesthesia using Propofol and Midazolam

Drug: Total intravenous anesthesia (TIVA); Drug: Rescue fentanyl

Inhalation Anesthesia

ACTIVE COMPARATOR

Patients will receive Inhalation anesthesia using Sevoflurane

Drug: Inhalation Anesthesia; Drug: Rescue fentanyl

Interventions

Total intravenous anesthesia (TIVA) DRUG

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

Total intravenous anesthesia (TIVA)

Inhalation Anesthesia DRUG

Sevoflurane at a concentration of 2-2.5%

Inhalation Anesthesia

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

Inhalation Anesthesia; Total intravenous anesthesia (TIVA)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status III or IV.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Sherif A Mousa

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Inhalation

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sherif A Mousa, MD

  Professor

  STUDY CHAIR

• Mohammed A Ghanem, MD

  Associate Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: December 18, 2018
• Primary Completion: December 15, 2019
• Study Completion: January 10, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

EG (1)