Clinical trial NCT06134037: Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Burst Suppression Occurence
Official title: Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Start and End of Burst Suppression Occurence and on BIS (Bispectral Index) During the Induction Phase of Total Intravenous Anaesthesia With TCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Brain Monitoring
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Correlation between Concentration at the effector site of Propofol after Aminophylline bolus during Burst Suppression occurence
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
state: TV
Study officials:
References: