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

NCT06134037 | Completed DMC

• 1 other identifier: TeoBurst
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Brain Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Aminophylline DRUG

Patients will be observationally included in the Aminophylline or not Aminiophylline group depending on anesthesiologist's discretion.

Aminophylline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

Location

MeSH Terms

Interventions

Aminophylline

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: November 12, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 15, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

IT (1)