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

NCT04129112 | Completed

• 1 other identifier: CorMA
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Awareness, Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Concentration of propofol at body movements

  Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery

• Concentration of propofol at return of consciousness

  Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery

Study Arms (2)

Patients without body movements

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

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

Patients with body movements

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

Drug: We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand 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 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; Patients without body movements

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

we recruited adult (\> 18 years old) undergoing general surgery in Treviso Regional Hospital. We excluded patients with any neurological or psychiatric or cerebrovascular diseases and renal insufficiency in anamnesis, who were unable to understand the information contained in the informed consent form, and patients with intraoperative hemodynamic instability or who was delivered curare agents during anaesthesia.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

ULSS 2 Marca Trevigiana

Treviso, Tv, 31100, Italy

Location

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal investigator

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: July 1, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

IT (1)