Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Burst Suppression Occurence (TCI)

Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Start and End of Burst Suppression Occurence and on BIS (Bispectral Index) During the Induction Phase of Total Intravenous Anaesthesia With TCI

Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its effects in lightining the anesthestic plan during Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

Authors aimed to compare its effect during accidental episodes of Burst Suppression during the induction phase of total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.

Study Overview

• Status: Completed
• Conditions: Anesthesia Brain Monitoring
• Intervention / Treatment: Drug: Aminophylline

Detailed Description

Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg, and also to lightining the anestetic plan (increase in Bipectral Index - BIS- values).

Authors aimed to compare its effect during accidental Burst Suppression episodes during the induction of total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital, with Eleveld Pharmacokinetic/Pharmacodynamic-PK/PD model).

The timing and relative Concentration of Propofol (CeP) from the start to the end of Burst suppression episodes with or without aminophylline bolus deliveres as soon as detected were taken into account.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Italy
  • TV
    • Treviso, TV, Italy, 31100
      • Treviso Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, with or without aminophylline bolus at Burst Suppression occurence during induction will be recruited

Description

Inclusion Criteria:

• Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Remifentanil (Minto model)
• Burst Suppression accidental occurence during the induction phase of anesthesia.

Exclusion Criteria:

• Neurological disease
• Psychiatric disease
• Obesity
• Hypothension during Burst Suppression episodes, other Burst suppression episodes during Anesthesia maintenance.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aminophylline; Patients who received Aminophylline bolus (4 mg/kg) at Burst Suppression occurence during induction of general anesthesia conducted with Eleveld TCI model	Drug: Aminophylline; Patients will be observationally included in the Aminophylline or not Aminiophylline group depending on anesthesiologist's discretion.
Not Aminophylline; Patients who did not received Aminophylline bolus (4 mg/kg) at Burst Suppression occurence during induction of general anesthesia conducted with Eleveld TCI model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Concentration at the effector site of Propofol after Aminophylline bolus during Burst Suppression occurence	Discover if, after an aminophylline bolus, there are differences between Concentrations at the effector site of Propofol and timing of Burst Suppression duration during standard general anaesthesia conducted with Propofol and remifentanil delivered with target controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia	Authors will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of anaesthesia until the emergence from anesthesia

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Protective Agents; Cardiotonic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Aminophylline
• Other Study ID Numbers: TeoBurst

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No