Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance

NCT02999126 | Unknown Phase 4 DMC

• 1 other identifier: 2884
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Target Controlled Infusion; Induction of Anesthesia; Bispectral Index

Keywords

Total Intravenous Anesthesia; Titration; Target Controlled Infusion; Propofol; Bispectral index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time for loss of consciousness

  Up to First 10 minutes, from start of propofol infusion at time 0 until loss of verbal response

• Effect Site Concentration required for loss of consciousness

  Up to first 10 minutes. It will be considered the propofol effect site concentration displayed at the moment loss of consciousness is achieved.

Study Arms (2)

Group 1

EXPERIMENTAL

Patients \< 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS \<40 or \>65 propofol target concentration will be modified by 0,3 mcg/ml.

Drug: Propofol; Drug: Remifentanil Hydrochloride

Group 2

EXPERIMENTAL

Patients ≥ 65 years old Propofol 1% TCI induction using plasma concentration, Marsh model (Ke0=0.26 min-1) at 1 mcg/ml, increasing the target concentration by 0.5 mcg/ml every minute until LOC. Remifentanil TCI 6 ng/ml and a neuromuscular relaxant will be administered afterwards in order to perform endotracheal intubation. CeLOC propofol concentration will be established and it will be observed for another 30 minutes. If BIS \<40 or \>65 propofol target concentration will be modified by 0,3 mcg/ml.

Drug: Propofol; Drug: Remifentanil Hydrochloride

Interventions

Propofol DRUG

Propofol intravenously by a stepwise TCI titration with Marsh pharmacokinetic model

Also known as: Fresofol

Group 1; Group 2

Remifentanil Hydrochloride DRUG

Remifentanil intravenously 6 ng/ml by TCI effect site, 3 min prior to intubation and maintained at that concentration throughout the study. If clinical signs of inadequate analgesia are present, remifentanil target concentration will be increased by 1 ng/ml.

Group 1; Group 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

RECRUITING

Related Publications (6)

• 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. doi: 10.1111/j.1365-2044.1998.00279.x.

  PMID: 9505735 BACKGROUND

• 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.

  PMID: 20190259 BACKGROUND

• 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. doi: 10.1016/s1734-1140(12)70874-5.

  PMID: 23087131 BACKGROUND

• 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):107-110. doi: 10.1213/01.ANE.0000139358.15909.EA.

  PMID: 15616062 BACKGROUND

• 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.

  PMID: 21624964 BACKGROUND

• Sepulveda PO, Cortinez LI, Recart A, Munoz 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.

  PMID: 20003124 BACKGROUND

MeSH Terms

Interventions

Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hernán Boveri, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hernán Boveri, MD

CONTACT

hernan.boveri@hospitalitaliano.org.ar

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 21, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)