Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02999126
• Date of registration: 08/12/2016
• Prospective Registration: No
• Primary sponsor: Hospital Italiano de Buenos Aires
• Public title: Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance (TITINDUC)
• Scientific title: Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance
• Date of first enrolment: August 2016
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02999126
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Participant).
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Hernán Boveri, MD

• Name: Hernán Boveri, MD

• Name: Hernán Boveri, MD
• Affiliation: Hospital Italiano de Buenos Aires

Key inclusion & exclusion criteria

Inclusion Criteria:

- ASA 1 or 2.

- Age over 20 years old.

- Scheduled to undergo elective surgery of minor or medium complexity under general
anesthesia.

- Regarding cognitive function: subjects will be considered with enough cognitive
function if they are able to read and understand the medical history form by properly
answering medical questions during the preoperative anesthesia assessment and being
also able to sign the informed consent form.

Exclusion Criteria:

- Pregnancy.

- Obesity (BMI >30).

- Patients taking benzodiazepines or other central nervous system action drugs.

- Subjects with psychiatric disorders with or without treatment.

- Allergies or any adverse reaction to propofol or any of its components (egg lecithin).



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bispectral Index

Induction of Anesthesia

Target Controlled Infusion

Intervention(s)

Drug: Remifentanil Hydrochloride

Drug: Propofol

Primary Outcome(s)

Time that BIS range remains within 45 and 65 after a stepwise TCI titration [Time Frame: A 30-minute period, starting 10 minutes after Remifentanil infusion (when propofol and remifentanil plasma-effect compartment equilibration has been reached)]

Secondary Outcome(s)

Effect Site Concentration required for loss of consciousness [Time Frame: Up to first 10 minutes. It will be considered the propofol effect site concentration displayed at the moment loss of consciousness is achieved.]

Time for loss of consciousness [Time Frame: Up to First 10 minutes, from start of propofol infusion at time 0 until loss of verbal response]

Secondary ID(s)

2884

Source(s) of Monetary Support

Please refer to primary and secondary sponsors