Total Intravenous Anesthesia: TCI Versus MCI

September 4, 2014 updated by: Riccardo Ragazzi, Università degli Studi di Ferrara

Total Intravenous Anesthesia: TCI Versus MCI, Unresolved Question

test the following differences between Schinder's Target Controlled Infusion (TCI ) model and manually controlled infusion (MCI) :

  • remifentanil and propofol total dose given
  • incidence of awareness or inadequate anesthesia
  • number of rescue dose given

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44121
        • 0532206570

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing breast or thyroid surgery

Exclusion Criteria:

  • BMI > 35
  • Surgery shorter than 30 minutes
  • Patients with history of: alcol or drug abuse, kidney or liver failure, cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCI
manually controlled infusion will be used
Device: Remifentanil and propofol administration using MCI
Experimental: TCI
Target Controlled Infusion will be used
Device: Remifentanil and propofol administration using TCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of awareness or inadequate anesthesia
Time Frame: every 3 minutes till the end of surgery
every 3 minutes till the end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
remifentanil and propofol total dose given
Time Frame: every 30 minutes till the end of surgery
every 30 minutes till the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15022014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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