Quantitative Electroencephalogram and Bispectral Index Brain Mapping During Propofol vs Sevoflurane General Anesthesia

NCT05102422 | Completed

• 1 other identifier: brainmap
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

General anesthesia interferes with the whole cerebral cortex at different levels. The goal was to investigate the impact of general anesthesia on different regions of the cerebral cortex by recording the brain's electrophysiological activity using QEEG and BIS during general anesthesia for 40 patients undergoing orthopedic surgeries under general anesthesia to see whether our hypothesis, that there is a topographically-dependent impact of general anesthesia on different regions of the cerebral cortex, is valid or not. The patients were randomly divided into 2 groups of 20 patients to compare the effect on the brain function monitoring (QEEG vs BIS) of the intravenous anesthesia (propofol) with the halogenated anesthesia (sevoflurane). And finally, we compared the two brain function monitoring techniques, BIS and QEEG.

Conditions

Neurophysiology

Keywords

General anesthetics; Bispectral index; Quantitative electroencephalography; Monitoring

Outcome Measures

Primary Outcomes (4)

• Frequency domain analysis QEEG

  Spectral Edge Frequency (Hz) and Median EEG Frequency (Hz) in the four cerebral cortical territories considered (PreFrontal Fp1; Temporal T7; Parietal and Occipital)

  intraoperatively

• Time domain analysis QEEG

  BSR (Burst Suppression Ratio) in % in the four cerebral cortical territories considered

  intraoperatively

• Power domain analysis QEEG

  Total Spectral Power (TSP) in the four cerebral cortical territories considered

  intraoperatively

• BIS

  BIS recordings in the four cerebral cortical territories studied

  intraoperatively

Study Arms (2)

1-Propofol

Induction and maintenance of general anesthesia using the intravenous anesthetic. Every patient received an intravenous bolus of 0,2 μg.kg-1 sufentanil, and the propofol (P) infusion was started using target-controlled infusion (TCI - Schnider's pharmacokinetic/pharmacodynamic data set); targeting the effect-concentration of 3 µg.ml-1. The effect concentration was gradually increased by 1µg.ml-1 every 2 to 3 minutes until loss of consciousness occurred. 0.1 mg.kg-1 of iv cisatracurium was given to prepare definitive intubation. The P effect-concentration were increased of 1 µg.ml-1 until test laryngoscope was successful and oro-tracheal intubation was performed. The effect concentration of propofol is reduced to 3 to 4 µg.ml-1 while awaiting the surgical incision. It is then left to the discretion of the anesthetist to add either an iv bolus of sufentanil (0.1 μg.kg-1) and/or an iv bolus of cisatracurium (0.1 mg.kg-1) only if necessary, in the clinical judgment of the practitioner.

Drug: Propofol 1 % Injectable Suspension

2-Sevoflurane

Induction and maintenance of general anesthesia using the inhaled anesthetic sevoflurane. Every patient received an intravenous (iv) bolus of 0,2 μg.kg-1 sufentanil, then sevoflurane (S) is started at one minimal alveolar concentration (2% in 50% oxygen) during mask assisted ventilation. The S concentration is gradually incremented by 2% until the LOC when the mask ventilation became fully assisted. 0.1 mg.kg-1 of iv cisatracurium was given to prepare definitive intubation. The S end-tidal concentration were increased of 1% until the test laryngoscope was successful and oro-tracheal intubation was performed. The end-tidal concentration of sevoflurane is reduced to one MAC while awaiting the surgical incision. After surgical incision, it is left to the discretion of the anesthetist to add either an iv bolus of sufentanil (0.1 μg.kg-1) and/or an iv bolus of cisatracurium (0.1 mg.kg-1) only if necessary, in the clinical judgment of the practitioner.

Drug: Sevoflurane inhalant product

Interventions

Propofol 1 % Injectable Suspension DRUG

Induction and maintenance of general anesthesia using the intravenous anesthetic

Also known as: Diprivan

1-Propofol

Sevoflurane inhalant product DRUG

Induction and maintenance of general anesthesia using the inhaled anesthetic sevoflurane

Also known as: Sevorane

2-Sevoflurane

Eligibility Criteria

• Age: 18 Years - 87 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for an orthopedic surgery to be operated in Erasme hospital, Belgium

You may qualify if:

• Non-obese (BMI\<27)
• American Society of Anesthesiologists (ASA) I and II (classification of the American Society of Anesthesiologists) adult patients
• Undergoing an orthopedic surgery
• Under general anesthesia
• Supine position

You may not qualify if:

• History of allergy, intolerance, or reaction to propofol or to sufentanil or hypersensitivity to either drug
• History of allergy, intolerance or reaction to sevoflurane or hypersensitivity to this drug
• History of malignant hyperthermia to sevoflurane or other halogenated gaz
• History of allergy, intolerance, or reaction to cisatracurium or hypersensitivity to this drug
• Any history of neurologic, neurovascular, neurosurgical, or psychiatric active pathology within past 6 months
• History of allergy to egg, soy, or lecithin
• Uncontrolled arterial hypertension
• Unstable cardiac status (life-threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction)
• Concomitant use of opioids, b-receptor antagonist, a2-receptor agonist or calcium channel blocker
• Currently receiving pharmacological agents for hypertension or cardiac disease
• Currently receiving or has received digoxin within the past 3 months BMI \>28 kg m²
• Active, uncontrolled gastro-oesophageal reflux - an aspiration risk
• Current (or within past 3 months) history of apnea requiring an apnea monitor
• Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
• Active, current respiratory issues different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus)

Sponsors & Collaborators

• Pierre Pandin: lead

Related Publications (5)

• John ER, Prichep LS, Kox W, Valdes-Sosa P, Bosch-Bayard J, Aubert E, Tom M, di Michele F, Gugino LD. Invariant reversible QEEG effects of anesthetics. Conscious Cogn. 2001 Jun;10(2):165-83. doi: 10.1006/ccog.2001.0507.

  PMID: 11414713 BACKGROUND

• John ER, Prichep LS. The anesthetic cascade: a theory of how anesthesia suppresses consciousness. Anesthesiology. 2005 Feb;102(2):447-71. doi: 10.1097/00000542-200502000-00030. No abstract available.

  PMID: 15681963 BACKGROUND

• Cimenser A, Purdon PL, Pierce ET, Walsh JL, Salazar-Gomez AF, Harrell PG, Tavares-Stoeckel C, Habeeb K, Brown EN. Tracking brain states under general anesthesia by using global coherence analysis. Proc Natl Acad Sci U S A. 2011 May 24;108(21):8832-7. doi: 10.1073/pnas.1017041108. Epub 2011 May 9.

  PMID: 21555565 BACKGROUND

• Hudetz AG. General anesthesia and human brain connectivity. Brain Connect. 2012;2(6):291-302. doi: 10.1089/brain.2012.0107.

  PMID: 23153273 BACKGROUND

• Pandin P, Van Cutsem N, Tuna T, D'hollander A. Bispectral index is a topographically dependent variable in patients receiving propofol anaesthesia. Br J Anaesth. 2006 Nov;97(5):676-80. doi: 10.1093/bja/ael235. Epub 2006 Aug 23.

  PMID: 16928697 BACKGROUND

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Pierre Pandin, MD

  Erasme University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 1, 2021
• Study Start: August 21, 2007
• Primary Completion: December 15, 2009
• Study Completion: December 15, 2009
• Last Updated: November 1, 2021

Record last verified: 2021-10