CClinicalTrials.gg
CompletedNCT06134037TCIUpdated Apr 25, 2024

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

An observational study in Anesthesia Brain Monitoring, sponsored by University of Padova. Completed at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by University of Padova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia Brain Monitoring
03

In context

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
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

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

Exclusion Criteria:

  • Neurological disease
  • Psychiatric disease
  • Obesity
  • Hypothension during Burst Suppression episodes, other Burst suppression episodes during Anesthesia maintenance.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugAminophylline

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

06

What researchers measure

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

    Time frame: 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

07

Study locations

1 site
  • Treviso Regional Hospital
    Treviso, TV 31100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06134037
Lead sponsor
University of Padova
Responsible party
Federico Linassi (MD, University of Padova) — Principal investigator
First posted
Nov 18, 2023
Start date
Nov 12, 2023
Primary completion
Feb 28, 2024
Completion
Mar 15, 2024
Last update
Apr 25, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion