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

NCT ID: NCT06134037

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-12
• Study Completion Date: 2024-03-15

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.

Conditions

Anesthesia Brain Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Aminophylline

Patients who received Aminophylline bolus (4 mg/kg) at Burst Suppression occurence during induction of general anesthesia conducted with Eleveld TCI model

Aminophylline

Intervention Type: DRUG

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

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

No interventions assigned to this group

Interventions

Aminophylline

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Federico Linassi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Treviso Regional Hospital

Treviso, TV, Italy

Countries

Italy

Other Identifiers

TeoBurst

Identifier Type: -

Identifier Source: org_study_id