Total Intravenous Anesthesia: TCI Versus MCI

NCT ID: NCT02077478

Last Updated: 2014-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Test the Differences Between Schinder's TCI Model and MCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MCI

manually controlled infusion will be used

Group Type EXPERIMENTAL

Remifentanil and propofol administration using MCI

Intervention Type DEVICE

TCI

Target Controlled Infusion will be used

Group Type EXPERIMENTAL

Remifentanil and propofol administration using TCI

Intervention Type DEVICE

Interventions

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Remifentanil and propofol administration using TCI

Intervention Type DEVICE

Remifentanil and propofol administration using MCI

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Riccardo Ragazzi

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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0532206570

Ferrara, , Italy

Site Status

Countries

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Italy

References

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Russell D. Intravenous anaesthesia: manual infusion schemes versus TCI systems. Anaesthesia. 1998 Apr;53 Suppl 1:42-5. doi: 10.1111/j.1365-2044.1998.53s113.x.

Reference Type BACKGROUND
PMID: 9640114 (View on PubMed)

Other Identifiers

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15022014

Identifier Type: -

Identifier Source: org_study_id

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