Slow Stepwise Propofol TCI Induction for Titration Anesthesia Maintenance

NCT02999126 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-02-18

No results posted yet for this study

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

Interventions

DRUG

Propofol

Propofol intravenously by a stepwise TCI titration with Marsh pharmacokinetic model

DRUG

Remifentanil Hydrochloride

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.

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    lead OTHER

Principal Investigators

  • Hernán Boveri, MD · Hospital Italiano de Buenos Aires

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02999126 on ClinicalTrials.gov