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

Propofol Clinical Trial

— TCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098196
• Other study ID #: Teoawake
• Status: Completed
• Start date: October 25, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 15, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Propofol

Intervention

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

Locations

Country	Name	City	State
Italy	ULSS 2 Marca Trevigiana	Treviso	Tv
Italy	ULSS2 Marca Trevigiana	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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