Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming

February 14, 2022 updated by: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove

Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.

This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Awareness is possible in TIVA in case of technical failure or prolonged induction phase, TCI technology seems to prevent these events. Total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. First half will be anesthetized using TIVA with manual induction and the second half will be anesthetized using TCI. All patients will fulfil Modified Brice Questionnaire one hour after the end of operation.

Study Type

Interventional

Enrollment (Anticipated)

80

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 Contact

Study Locations

  • Czechia
      • Hradec Kralove, Czechia, 50005
        • Recruiting
        • University Hospital Hradec Kralove

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Glasgow Coma scale 15
  • ASA Physical Status Classification System I - III
  • planed surgery for brain tumor to 5 hours
  • postoperative awakening

Exclusion Criteria:

  • NYHA III, IV
  • abuse of stimulating drugs, grass, alcohol dependence
  • BMI over 40 in females and over 35 in men
  • propofol alergie
  • awake operations
  • postoperative arteficial ventilation

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group TCI
induction and anesthesia will be held by using target-controll infusion
Procedure: Group TCI
Induction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35.
ACTIVE_COMPARATOR: Group TIVA
induction and anesthesia will be held by manual dosing of propofol and sufentanil
Procedure: Group TIVA
Induction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg/kg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg/ kg/hour and sufentanil 35 ug/hour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of awareness
Time Frame: 5 hours
consciousness during operation
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of haemodynamical instability
Time Frame: 5 hours
reduction of blood pressure by 25 %
5 hours
reduction of norepinephrine dose
Time Frame: 5 hours
reduction in ugs during the whole operation
5 hours

Collaborators and Investigators

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

Sponsor

University Hospital Hradec Kralove

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 (ACTUAL)

March 16, 2018

Primary Completion (ANTICIPATED)

December 15, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (ACTUAL)

March 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201506S

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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