Total Intravenous Anesthesia: TCI Versus MCI

Test the Differences Between Schinder's TCI Model and MCI Clinical Trial

Official title:

Total Intravenous Anesthesia: TCI Versus MCI, Unresolved Question

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077478
• Other study ID #: 15022014
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: September 4, 2014
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Test the Differences Between Schinder's TCI Model and MCI

Intervention

Device:
• Remifentanil and propofol administration using TCI

• Remifentanil and propofol administration using MCI

Locations

Country	Name	City	State
Italy	0532206570	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Russell D. Intravenous anaesthesia: manual infusion schemes versus TCI systems. Anaesthesia. 1998 Apr;53 Suppl 1:42-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of awareness or inadequate anesthesia		every 3 minutes till the end of surgery	Yes
Secondary	remifentanil and propofol total dose given		every 30 minutes till the end of surgery	Yes