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

Primary Purpose

Anesthesia Awareness

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Group TCI
Group TIVA
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia Awareness focused on measuring Anesthesia Awareness, Dreaming in anesthesia, Total intravenous anesthesia, Target-controll infusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Hradec KraloveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group TCI

Group TIVA

Arm Description

induction and anesthesia will be held by using target-controll infusion

induction and anesthesia will be held by manual dosing of propofol and sufentanil

Outcomes

Primary Outcome Measures

reduction of awareness
consciousness during operation

Secondary Outcome Measures

reduction of haemodynamical instability
reduction of blood pressure by 25 %
reduction of norepinephrine dose
reduction in ugs during the whole operation

Full Information

First Posted
March 9, 2018
Last Updated
February 14, 2022
Sponsor
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT03476213
Brief Title
Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming
Official Title
Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Awareness
Keywords
Anesthesia Awareness, Dreaming in anesthesia, Total intravenous anesthesia, Target-controll infusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A will be anesthetized using TIVA, group B using TCI
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group TCI
Arm Type
Experimental
Arm Description
induction and anesthesia will be held by using target-controll infusion
Arm Title
Group TIVA
Arm Type
Active Comparator
Arm Description
induction and anesthesia will be held by manual dosing of propofol and sufentanil
Intervention Type
Procedure
Intervention Name(s)
Group TCI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group TIVA
Intervention Description
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.
Primary Outcome Measure Information:
Title
reduction of awareness
Description
consciousness during operation
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
reduction of haemodynamical instability
Description
reduction of blood pressure by 25 %
Time Frame
5 hours
Title
reduction of norepinephrine dose
Description
reduction in ugs during the whole operation
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vlasta Dostalova, MD. Ph.D.
Phone
+420777883571
Email
vlasta.dostalova@fnhk.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Dostal, MD, Ph.D.
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suchy Tomas, MD
Phone
00420495833218
Email
suchy@fnhk.cz
First Name & Middle Initial & Last Name & Degree
Dostal Pavel, MD, PhD
Phone
00420495832828
Email
pavel.dostal@fnhk.cz

12. IPD Sharing Statement

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

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