Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness (TCI)

Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness and on BIS (Bispectral Index) After 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 utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

We aimed to compare its effect during a total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.

Study Overview

• Status: Completed
• Conditions: Propofol; Anesthesia Brain Monitoring
• Intervention / Treatment: Drug: Aminophyllin

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.

We aimed to compare its effect during a total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital (with Eleveld or Schnider Pharmacokinetic/Pharmacodynamic-PK/PD model).

The timing from stop of propofol infusion to eye opening and return of responsiveness, the relative Concentration of Propofol (CeP) and the power spectrum of the Bispectral Index (BIS) with or without aminophylline bolus were taken into account.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Italy
  • Treviso, Italy, 31100
    • ULSS2 Marca Trevigiana
  • Tv
    • Treviso, Tv, Italy, 31100
      • ULSS 2 Marca Trevigiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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 the end of surgery will be recruited

Description

Inclusion Criteria:

• Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

• Neurological disease
• Psychiatric disease
• Obesity

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 the end of general anesthesia conducted with Eleveld or Schnider TCI model (this model was chosen at anesthesiologist's discretion)	Drug: Aminophyllin; Patients will be observationally included in the Elveld TCI or Schnider TCI group and recevied or not Aminiophylline bolus. The TCI model, such as the aminophylline delivery or not, is chosen at anesthesiologist's discretion, as suggested in literature
Not Aminophylline; Patients who did not received Aminophylline bolus (4 mg/kg) at the end of general anesthesia conducted with Eleveld or SchniderTCI model (this model was chosen at anesthesiologist's discretion	Drug: Aminophyllin; Patients will be observationally included in the Elveld TCI or Schnider TCI group and recevied or not Aminiophylline bolus. The TCI model, such as the aminophylline delivery or not, is chosen at anesthesiologist's discretion, as suggested in literature

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	Discover if, after an aminophylline bolus, there are differences between Concentrations at the effector site and timing at eye opening of Propofol using the Eleveld TCI model or Schnider TCI model, after standard general anaesthesia conducted with Propofol and remifentanil delivered with target controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia	We 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): October 25, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 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: Teoawake

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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