Target Controlled Infusion Clinical Trial
— (TITINDUC)Official title:
Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance
NCT number | NCT02999126 |
Other study ID # | 2884 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | March 2021 |
The purpose of this study is to determine if a slow stepwise propofol TCI induction with Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration required for maintenance of the general anesthesia, with propofol and remifentanil, in adult populations older and younger than 65 years of age.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Italiano de Buenos Aires | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Hospital Italiano de Buenos Aires |
Argentina,
Bienert A, Wiczling P, Grzeskowiak E, Cywinski JB, Kusza K. Potential pitfalls of propofol target controlled infusion delivery related to its pharmacokinetics and pharmacodynamics. Pharmacol Rep. 2012;64(4):782-95. Review. — View Citation
Coppens M, Van Limmen JG, Schnider T, Wyler B, Bonte S, Dewaele F, Struys MM, Vereecke HE. Study of the time course of the clinical effect of propofol compared with the time course of the predicted effect-site concentration: Performance of three pharmacokinetic-dynamic models. Br J Anaesth. 2010 Apr;104(4):452-8. doi: 10.1093/bja/aeq028. Epub 2010 Feb 26. Erratum in: Br J Anaesth. 2019 Feb;122(2):287. — View Citation
Iwakiri H, Nishihara N, Nagata O, Matsukawa T, Ozaki M, Sessler DI. Individual effect-site concentrations of propofol are similar at loss of consciousness and at awakening. Anesth Analg. 2005 Jan;100(1):107-10. — View Citation
Sepúlveda PO, Cortínez LI, Recart A, Muñoz HR. Predictive ability of propofol effect-site concentrations during fast and slow infusion rates. Acta Anaesthesiol Scand. 2010 Apr;54(4):447-52. doi: 10.1111/j.1399-6576.2009.02183.x. Epub 2009 Dec 14. — View Citation
Struys M, Versichelen L, Byttebier G, Mortier E, Moerman A, Rolly G. Clinical usefulness of the bispectral index for titrating propofol target effect-site concentration. Anaesthesia. 1998 Jan;53(1):4-12. — View Citation
Struys MM, Sahinovic M, Lichtenbelt BJ, Vereecke HE, Absalom AR. Optimizing intravenous drug administration by applying pharmacokinetic/pharmacodynamic concepts. Br J Anaesth. 2011 Jul;107(1):38-47. doi: 10.1093/bja/aer108. Epub 2011 May 30. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time that BIS range remains within 45 and 65 after a stepwise TCI titration | TCI Effect Site Concentration achieved at LOC, depth of anesthesia will be recorded with BIS bilateral sensor | A 30-minute period, starting 10 minutes after Remifentanil infusion (when propofol and remifentanil plasma-effect compartment equilibration has been reached) | |
Secondary | Time for loss of consciousness | In seconds, using TCI induction with Marsh 4.0 pharmacokinetic model | Up to First 10 minutes, from start of propofol infusion at time 0 until loss of verbal response | |
Secondary | Effect Site Concentration required for loss of consciousness | In mcg/ml, using Marsh Pharmacokinetic Model, Ke0 0.26 min-1 | Up to first 10 minutes. It will be considered the propofol effect site concentration displayed at the moment loss of consciousness is achieved. |
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