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

ConditionAnesthesia Awareness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Hradec Kralove

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Glasgow Coma scale 15

ASA Physical Status Classification System I - III

planed surgery for brain tumor to 5 hours

postoperative awakening

Disqualifiers

NYHA III, IV

abuse of stimulating drugs, grass, alcohol dependence

BMI over 40 in females and over 35 in men

propofol alergie

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group TCI

    Procedure/Surgery

    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.

  • Group TIVA

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group TCIExperimental treatment 1 intervention
Group B: Group TIVAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

reduction of awareness

consciousness during operation

Time frame
5 hours

Secondary outcomes

1

reduction of haemodynamical instability

reduction of blood pressure by 25 %

Time frame
5 hours
2

reduction of norepinephrine dose

reduction in ugs during the whole operation

Time frame
5 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Hradec Kralove

Lead sponsor

Source ClinicalTrials.gov
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