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

NCT06098196 | Completed

• 1 other identifier: Teoawake
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Propofol; Anesthesia Brain Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Aminophyllin DRUG

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

Aminophylline; Not Aminophylline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• 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 the end of surgery will be recruited

You may qualify if:

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

You may not qualify if:

• Neurological disease
• Psychiatric disease
• Obesity

Sponsors & Collaborators

• University of Padova: lead

Study Sites (2)

ULSS 2 Marca Trevigiana

Treviso, Tv, 31100, Italy

Location

ULSS2 Marca Trevigiana

Treviso, 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, Principal investigator

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: October 25, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 15, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

IT (2)