TCI vs Manually Controlled Infusion of Propofol

TCI vs Manually Controlled Infusion of Propofol in Patients Sceduled for Laparoscopic Surgery; a Case-control Study

Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion.

The aim of the study is to verify differences in time to extubation and amount of drugs used.

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Study Overview

• Status: Unknown
• Conditions: Airway Extubation; Laparotomy; Anesthesia, Intravenous
• Intervention / Treatment: Device: Target controlled infusion

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Anestectic records

Description

Inclusion Criteria:

- Patients to laparoscopic surgery

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TCI; Patients receiving Target Controlled Infusion (TCI) Anesthesia	Device: Target controlled infusion; Target controlled infusion vs manually controlled infusion
MCI; Patients receiving Manually Controlled Infusion (MCI) Anesthesia	Device: Target controlled infusion; Target controlled infusion vs manually controlled infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post procedural awakening	Time from the surgical procedure has ended until arrival at the post anesthesia unit (PACU)	10 minutes

Collaborators and Investigators

• Sponsor: Regional Hospital West Jutland

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TCI/RHWJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR