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

NCT ID: NCT04129112

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-12-15

Brief 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.

Detailed 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.

Conditions

Awareness, Anesthesia

Study Design

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

Study Groups

Patients without body movements

Patient who, under general anesthesia without curare agents, during surgery has no body movements

We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening

Intervention Type: DRUG

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

Patients with body movements

Patient who, under general anesthesia without curare agents, during surgery has any body movements that are no reflexes movements

We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Federico Linassi

MD, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ULSS 2 Marca Trevigiana

Treviso, Tv, Italy

Countries

Italy

Other Identifiers

CorMA

Identifier Type: -

Identifier Source: org_study_id