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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03476213
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove

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.

Condition or disease Intervention/treatment
Anesthesia Awareness Procedure: Group TCI Procedure: Group TIVA

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A will be anesthetized using TIVA, group B using TCI
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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).
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.

Primary Outcome Measures :
  1. reduction of awareness [ Time Frame: 5 hours ]
    consciousness during operation

Secondary Outcome Measures :
  1. reduction of haemodynamical instability [ Time Frame: 5 hours ]
    reduction of blood pressure by 25 %

  2. reduction of norepinephrine dose [ Time Frame: 5 hours ]
    reduction in ugs during the whole operation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03476213

Contact: Vlasta Dostalova, MD. Ph.D. +420777883571

University Hospital Hradec Kralove Recruiting
Hradec Kralove, Czechia, 50005
Contact: Suchy Tomas, MD    00420495833218   
Contact: Dostal Pavel, MD, PhD    00420495832828   
Sponsors and Collaborators
University Hospital Hradec Kralove
Study Director: Pavel Dostal, MD, Ph.D. University Hospital Hradec Kralove

Responsible Party: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove Identifier: NCT03476213     History of Changes
Other Study ID Numbers: 201506S
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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

Keywords provided by Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove:
Anesthesia Awareness
Dreaming in anesthesia
Total intravenous anesthesia
Target-controll infusion

Additional relevant MeSH terms:
Intraoperative Awareness
Intraoperative Complications
Pathologic Processes
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia