Evaluation of Influencing Variables in Awakening Concentration and Concentration at Body Movements of Propofol TCI (Targeted Controlled Infusion) Targeted at the Effector Site

Awareness, Anesthesia Clinical Trial

— TCI  

Official title:

Evaluation of Influencing Variables in Awakening Concentration and Concentration at Body Movements of Propofol TCI (Targeted Controlled Infusion) Targeted at the Effector Site

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129112
• Other study ID #: CorMA
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: October 2020
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Age has been related to awakening propofol concentration at effector site of TCI, but not to the loss of consciousness concentration, neither to the concentration of body movements during surgery, that can be interpreted as a sign of light anesthesia and lead to awareness.

This study aims to determinate the incidence and the propofol TCI concentration at the effector site, in patients undergoing general anaesthesia without NBDs, of any patients body movements, defined as any spontaneous movements (but no reflex movements) during surgery.

Description:

Target-Controlled-Infusion (TCI), estimating the effect-size concentration (Ce) of propofol and its elimination time with a computerized system, provides the anaesthesiologist useful information to guide anaesthesia.

Although the correlation between propofol at the effector site at loss of consciousness (Ce LOC) and age is still debated with contrasting results, the correlation between propofol at the effector site at return of consciousness (Ce ROC) and age is well established, and some authors suggested that, due also for age-related changes in both pharmacokinetics and pharmacodynamics of propofol, its dosage should be reduced in elderly patients.

Lowering propofol dosage however, can lead to an higher incidence of awareness during general anaesthesia, even if anaesthesia management is guided by consciousness monitors.

Awareness during anaesthesia has recently been defined not as a binary phenomenon, but as a graded spectra of states and, during general anaesthesia without using neuromuscular blocking drugs (NBDs), body movement on the operating table can be taken as an indication of increasing probability of consciousness or 'light' anaesthesia.

Hence, this study aims to evaluate the impact of age on the concentration at the effector site of propofol-remifentanil anaesthesia administered with TCI pump and without NBDs. Concnetration at the effector site of Propofol at the return of consciousness (CeP ROC) and at any clinical sign of superficialization such as body movements (CeP BM) will be considered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients undergoing general anesthesia with propofol and remifentanil delivered with TCI infusion pump

Exclusion Criteria:

• neurological or psychiatric or cerebrovascular diseases

• renal insufficiency

• patients unable to understand the information contained in the informed consent form,

• patients with intraoperative hemodynamic instability or

• patients who was delivered curare agents during anaesthesia

Related Conditions & MeSH terms

• Awareness, Anesthesia
• Intraoperative Awareness

Intervention

Drug:
• We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening
Propofol in our hospital is routinely delivered by Targeted Controlled Infusion (TCI) pumps. We note the concentration of propofol at the effector site of body movements and awakening

Locations

Country	Name	City	State
Italy	ULSS 2 Marca Trevigiana	Treviso	Tv

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of body movements in patients undergoing surgery without curare agents	We will note if patients have spontaneous movements during surgery, and calculate the incidence of the phenomenon.	During surgery
Secondary	Concentration of propofol at body movements	We will note the concentration at the effector site of propofol TCI during body movements and compare them to pre-operative and demographical variables (age, weight, height, American Society of Anaesthesiologist physical status classification system (ASA), number of previous general anaesthesia, years of schooling, Sort Portable Mental Status Questionnaire score) and intra-operative variables ( concentration at the effector site of remifentanil at ventilator maladjustment (CeR VM), mean Ce propofol and remifentanil target during maintenance, and maximum, mean and minimum State Entropy (SE) and Response Entropy (RE) values during maintenance).	Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery
Secondary	Concentration of propofol at return of consciousness	We will note the concentration at the effector site of propofol TCI at awakening and compare them to pre-operative and demographical variables (age, weight, height, American Society of Anaesthesiologist physical status classification system (ASA), number of previous general anaesthesia, years of schooling, Sort Portable Mental Status Questionnaire score) and intra-operative variables ( concentration at the effector site of remifentanil at ventilator maladjustement (CeR VM), mean Ce propofol and remifentanil target during maintenance, and maximum, mean and minimum SE and RE Entropy values during maintenance).	Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery